Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT03198000
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2017-06-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy of Investigational OTC Eye Drops
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'AParikh1@its.jnj.com', 'phone': '(973) 255-8701', 'title': 'Amisha Parikh-Das, PhD, MPH', 'organization': 'Johnson & Johnson Consumer Inc.'}, 'certainAgreement': {'otherDetails': "Prior to submission for publication, PI was to provide sponsor with ≥ 60 days for publication review. No publication that included sponsor confidential information was to be submitted without sponsor's prior written consent. If requested, the PI was to withhold publication for up to 60 additional days to allow for patent application filing.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through 24-hour end-of-study visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events', 'description': "AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit.", 'eventGroups': [{'id': 'EG000', 'title': 'F#13418-148/F#13418-158', 'description': 'Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'F#13418-148/F#PF004390', 'description': 'Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05%', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'F#13418-158/F#PF004390', 'description': 'Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05%', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.050', 'groupId': 'OG001'}, {'value': '0.32', 'spread': '0.049', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.392', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.140', 'ciUpperLimit': '0.055', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.049', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'Prespecified equivalence interval of (-0.22, 0.44).'}, {'pValue': '0.828', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.086', 'ciUpperLimit': '0.107', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.049', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'Prespecified equivalence interval of (-0.22, 0.44)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 60 seconds after first product application', 'description': 'Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Response to Redness at 60 Seconds After First Product Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}, {'value': '50.1', 'groupId': 'OG001'}, {'value': '50.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.576', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.539', 'ciUpperLimit': '1.411', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'GEE model with treatment as factor.', 'nonInferiorityComment': 'Prespecified equivalence interval of (0.80, 1.25).'}, {'pValue': '0.544', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.552', 'ciUpperLimit': '1.368', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'GEE model with treatment as factor.', 'nonInferiorityComment': 'Prespecified equivalence interval of (0.80, 1.25)'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 60 seconds after first product application', 'description': 'The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.046', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.046', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.893', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '0.074', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.040', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified for this time point.'}, {'pValue': '0.886', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.073', 'ciUpperLimit': '0.084', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.040', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified for this time point.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 30 seconds after first product application', 'description': 'Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.048', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '0.048', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.177', 'ciUpperLimit': '0.020', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.050', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified for this time point.'}, {'pValue': '0.255', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.153', 'ciUpperLimit': '0.041', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.049', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified for this time point.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 2 minutes after first product application', 'description': 'Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'Clinician Assessment of Baseline Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '0.537', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.497', 'groupId': 'OG001'}, {'value': '1.76', 'spread': '0.498', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified.'}, {'pValue': '0.269', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified for this time point.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 60 seconds after first product application', 'description': 'Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ocular Comfort at 10 Hours After First Product Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.162', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified.'}, {'pValue': '0.234', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified for this time point.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 10 hours after first product application', 'description': 'Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ocular Comfort at 12 Hours After First Product Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.398', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified.'}, {'pValue': '0.233', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.', 'nonInferiorityComment': 'No equivalence interval was specified for this time point.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 hours after first product application', 'description': 'Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Hydrated - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}, {'value': '28.0', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '34.1', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '19.5', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. 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Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Hydrated - 10 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '43.0', 'groupId': 'OG001'}, {'value': '29.3', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '41.5', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Hydrated - 12 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000'}, {'value': '40.5', 'groupId': 'OG001'}, {'value': '41.5', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '17.1', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Refreshed - 2 Minutes After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '42.7', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}, {'value': '36.6', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Refreshed - 10 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}, {'value': '32.9', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '45.6', 'groupId': 'OG001'}, {'value': '43.9', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Refreshed - 12 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '37.8', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'The Appearance of my Eye Gives me Confidence to Approach Others - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '31.6', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '39.2', 'groupId': 'OG001'}, {'value': '37.8', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '32.9', 'groupId': 'OG001'}, {'value': '36.6', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}, {'value': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}, {'value': '46.3', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '26.6', 'groupId': 'OG001'}, {'value': '28.0', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. 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Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. 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Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}, {'value': '35.4', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '43.0', 'groupId': 'OG001'}, {'value': '40.2', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '31.6', 'groupId': 'OG001'}, {'value': '32.9', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '31.7', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}, {'value': '24.4', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '32.9', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '40.2', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Appears Healthy - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}, {'value': '45.1', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '31.6', 'groupId': 'OG001'}, {'value': '25.6', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Appears Healthy - 2 Minutes After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}, {'value': '42.7', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}, {'value': '37.8', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Appears Healthy - 10 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}, {'value': '48.8', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '27.8', 'groupId': 'OG001'}, {'value': '28.0', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Appears Healthy - 12 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}, {'value': '47.6', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}, {'value': '28.0', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Cool - 2 Minutes After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}, {'value': '29.3', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}, {'value': '32.9', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '24.1', 'groupId': 'OG001'}, {'value': '25.6', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Cool - 10 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '34.1', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '25.3', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Feels Cool - 12 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}, {'value': '17.1', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '27.8', 'groupId': 'OG001'}, {'value': '29.3', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '24.4', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '10.1', 'groupId': 'OG001'}, {'value': '17.1', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Appears to Sparkle - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}, {'value': '19.5', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '38.0', 'groupId': 'OG001'}, {'value': '35.4', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Appears to Sparkle - 2 Minutes After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '26.6', 'groupId': 'OG001'}, {'value': '20.7', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '37.8', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Appears to Sparkle - 10 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}, {'value': '17.1', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}, {'value': '28.0', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '31.6', 'groupId': 'OG001'}, {'value': '29.3', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}, {'type': 'SECONDARY', 'title': 'My Eye Appears to Sparkle - 12 Hours After First Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'F# PF004390 Eye Drops', 'description': 'Active Comparator - Tetrahydrozoline 0.05%'}, {'id': 'OG001', 'title': 'F# 13418-148 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%'}, {'id': 'OG002', 'title': 'F#13418-158 Eye Drops', 'description': 'Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0%'}], 'classes': [{'title': 'Strongly agree (5)', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}, {'value': '19.5', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat agree (4)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}, {'value': '25.3', 'groupId': 'OG001'}, {'value': '24.4', 'groupId': 'OG002'}]}]}, {'title': 'Neither agree or disagree (3)', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '38.0', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'Somewhat disagree (2)', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'Strongly disagree (1)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Intent-to-treat set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'F#13418-148/F#13418-158', 'description': 'Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%'}, {'id': 'FG001', 'title': 'F#13418-148/F#PF004390', 'description': 'Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05%'}, {'id': 'FG002', 'title': 'F#13418-158/F#PF004390', 'description': 'Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 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#13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%'}, {'id': 'BG001', 'title': 'F#13418-148/F#PF004390', 'description': 'Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05%'}, {'id': 'BG002', 'title': 'F#13418-158/F#PF004390', 'description': 'Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05%'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '15.58', 'groupId': 'BG000'}, {'value': '59.1', 'spread': '13.85', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '12.47', 'groupId': 'BG002'}, {'value': '56.4', 'spread': '14.03', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Intent-to-treat set'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Intent-to-treat set'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}, {'title': 'Black or African-American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Intent-to-treat set'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Intent-to-treat set'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Intent-to-treat set'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-28', 'size': 1242702, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-27T14:30', 'hasProtocol': True}, {'date': '2017-06-19', 'size': 617655, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-27T14:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2017-06-22', 'resultsFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-13', 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application', 'timeFrame': 'Baseline to 60 seconds after first product application', 'description': 'Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.'}, {'measure': 'Percentage of Participants With Response to Redness at 60 Seconds After First Product Application', 'timeFrame': 'Baseline to 60 seconds after first product application', 'description': 'The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.'}], 'secondaryOutcomes': [{'measure': 'Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application', 'timeFrame': 'Baseline to 30 seconds after first product application', 'description': 'Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.'}, {'measure': 'Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application', 'timeFrame': 'Baseline to 2 minutes after first product application', 'description': 'Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.'}, {'measure': 'Clinician Assessment of Baseline Redness', 'timeFrame': 'Baseline', 'description': 'Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.'}, {'measure': 'Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application', 'timeFrame': 'Baseline to 60 seconds after first product application', 'description': 'Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.'}, {'measure': 'Change From Baseline in Ocular Comfort at 10 Hours After First Product Application', 'timeFrame': 'Baseline to 10 hours after first product application', 'description': 'Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.'}, {'measure': 'Change From Baseline in Ocular Comfort at 12 Hours After First Product Application', 'timeFrame': 'Baseline to 12 hours after first product application', 'description': 'Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.'}, {'measure': 'My Eye Feels Hydrated - Baseline', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Hydrated - 2 Minutes After First Application', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Hydrated - 10 Hours After First Application', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Hydrated - 12 Hours After First Application', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Refreshed - 2 Minutes After First Application', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Refreshed - 10 Hours After First Application', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Refreshed - 12 Hours After First Application', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'The Appearance of my Eye Gives me Confidence to Approach Others - Baseline', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'The Appearance of my Eye Can Show How I Really Feel - Baseline', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Appears Healthy - Baseline', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Appears Healthy - 2 Minutes After First Application', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Appears Healthy - 10 Hours After First Application', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Appears Healthy - 12 Hours After First Application', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Cool - 2 Minutes After First Application', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Cool - 10 Hours After First Application', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Feels Cool - 12 Hours After First Application', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Appears to Sparkle - Baseline', 'timeFrame': 'Baseline', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Appears to Sparkle - 2 Minutes After First Application', 'timeFrame': '2 minutes after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Appears to Sparkle - 10 Hours After First Application', 'timeFrame': '10 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}, {'measure': 'My Eye Appears to Sparkle - 12 Hours After First Application', 'timeFrame': '12 hours after first application', 'description': 'Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eye Redness', 'Eye Comfort', 'Red Eyes'], 'conditions': ['Ophthalmic Solutions']}, 'referencesModule': {'references': [{'pmid': '20082509', 'type': 'BACKGROUND', 'citation': 'Cronau H, Kankanala RR, Mauger T. Diagnosis and management of red eye in primary care. Am Fam Physician. 2010 Jan 15;81(2):137-44.'}, {'pmid': '8961843', 'type': 'BACKGROUND', 'citation': 'Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30.'}, {'pmid': '16518366', 'type': 'BACKGROUND', 'citation': 'Murphy PJ, Lau JS, Sim MM, Woods RL. How red is a white eye? Clinical grading of normal conjunctival hyperaemia. Eye (Lond). 2007 May;21(5):633-8. doi: 10.1038/sj.eye.6702295. Epub 2006 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.', 'detailedDescription': 'Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;\n2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research\n3. Male or female of any race or ethnicity, aged 18 years and older;\n4. Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);\n5. Able to read and understand English;\n6. Healthy subjects with redness in both eyes\n7. History of topical ocular drugs or desire to use within the last 6 months;\n8. Ocular health within normal limits,\n9. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.\n\nExclusion Criteria:\n\n1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);\n2. Known sensitivity, allergy or contraindications to any investigational product ingredient;\n3. Females who are pregnant, planning to become pregnant or breastfeeding during the study;\n4. Subjects who were previously screened and determined to be ineligible for the study;\n5. Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;\n6. Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);\n7. Relative, partner or staff of any clinical research site personnel;\n8. Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;\n9. Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;\n10. Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;\n11. Has a compromised immune system;\n12. Has any acute or chronic, medical or psychiatric conditions\n13. Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;\n14. Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;\n15. Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation."}, 'identificationModule': {'nctId': 'NCT03198000', 'briefTitle': 'A Study to Evaluate the Efficacy of Investigational OTC Eye Drops', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye', 'orgStudyIdInfo': {'id': 'CO-161103095739-VCCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Formula # 13418-148', 'interventionNames': ['Drug: F# 13418-148 Eye Drops']}, {'type': 'EXPERIMENTAL', 'label': 'Formula # 13418-158', 'interventionNames': ['Drug: F#13418-158 Eye Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Formula # PF004390', 'interventionNames': ['Drug: F# PF-004390 Eye Drops']}], 'interventions': [{'name': 'F# 13418-148 Eye Drops', 'type': 'DRUG', 'description': 'ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day', 'armGroupLabels': ['Formula # 13418-148']}, {'name': 'F#13418-158 Eye Drops', 'type': 'DRUG', 'description': 'ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day', 'armGroupLabels': ['Formula # 13418-158']}, {'name': 'F# PF-004390 Eye Drops', 'type': 'DRUG', 'description': 'Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day', 'armGroupLabels': ['Control Formula # PF004390']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Gail Torkildsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andover Eye Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Consumer Inc. (J&JCI)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}