Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-06-16 @ 4:24 PM
Study NCT ID:
NCT02455050
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Day 35', 'eventGroups': [{'id': 'EG000', 'title': 'New Eye Drop Formulation Then Systane®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Systane® Then New Eye Drop Formulation', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'New Eye Drop Formulation Then Genteal®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Genteal® Then New Eye Drop Formulation', 'description': '1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.'}], 'classes': [{'title': 'Positive Questions', 'categories': [{'measurements': [{'value': '255.74', 'spread': '119.69', 'groupId': 'OG000'}, {'value': '280.17', 'spread': '90.60', 'groupId': 'OG001'}, {'value': '284.89', 'spread': '86.18', 'groupId': 'OG002'}, {'value': '255.83', 'spread': '94.55', 'groupId': 'OG003'}]}]}, {'title': 'Negative Questions', 'categories': [{'measurements': [{'value': '86.11', 'spread': '87.83', 'groupId': 'OG000'}, {'value': '134.89', 'spread': '97.80', 'groupId': 'OG001'}, {'value': '101.53', 'spread': '102.00', 'groupId': 'OG002'}, {'value': '109.22', 'spread': '86.33', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14)', 'description': 'Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Participants enrolled in Period 1.'}, {'type': 'PRIMARY', 'title': 'Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG003', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}], 'classes': [{'title': 'Positive Questions', 'categories': [{'measurements': [{'value': '231.33', 'spread': '112.22', 'groupId': 'OG000'}, {'value': '295.00', 'spread': '60.52', 'groupId': 'OG001'}, {'value': '298.82', 'spread': '109.15', 'groupId': 'OG002'}, {'value': '272.12', 'spread': '125.20', 'groupId': 'OG003'}]}]}, {'title': 'Negative Questions', 'categories': [{'measurements': [{'value': '102.00', 'spread': '76.69', 'groupId': 'OG000'}, {'value': '120.00', 'spread': '71.23', 'groupId': 'OG001'}, {'value': '54.65', 'spread': '58.46', 'groupId': 'OG002'}, {'value': '98.53', 'spread': '85.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35)', 'description': 'Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Baseline_Period 1', 'categories': [{'measurements': [{'value': '34.76', 'spread': '13.88', 'groupId': 'OG000'}, {'value': '36.98', 'spread': '13.72', 'groupId': 'OG001'}, {'value': '37.39', 'spread': '15.99', 'groupId': 'OG002'}, {'value': '34.79', 'spread': '10.26', 'groupId': 'OG003'}]}]}, {'title': 'Follow-up 1_Day 14', 'categories': [{'measurements': [{'value': '27.45', 'spread': '23.49', 'groupId': 'OG000'}, {'value': '25.89', 'spread': '21.07', 'groupId': 'OG001'}, {'value': '22.85', 'spread': '25.55', 'groupId': 'OG002'}, {'value': '23.56', 'spread': '22.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)', 'description': 'The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Baseline_Period 2', 'categories': [{'measurements': [{'value': '21.98', 'spread': '21.85', 'groupId': 'OG000'}, {'value': '20.36', 'spread': '24.56', 'groupId': 'OG001'}, {'value': '18.06', 'spread': '16.77', 'groupId': 'OG002'}, {'value': '23.08', 'spread': '22.15', 'groupId': 'OG003'}]}]}, {'title': 'Follow-up 2_Day 35', 'categories': [{'measurements': [{'value': '25.88', 'spread': '24.04', 'groupId': 'OG000'}, {'value': '21.77', 'spread': '23.94', 'groupId': 'OG001'}, {'value': '19.65', 'spread': '15.60', 'groupId': 'OG002'}, {'value': '20.42', 'spread': '22.48', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)', 'description': 'The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Q1_Follow-up 1 Day 14', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Q2_Follow-up 1 Day 14', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}, {'title': 'Q3_Follow-up 1 Day 14', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'Q4_Follow-up 1 Day 14', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}]}, {'title': 'Q5_Follow-up 1 Day 14', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Q6_Follow-up 1 Day 14', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '47.3', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Q7_Follow-up 1 Day 14', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Q8_Follow-up 1 Day 14', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14)', 'description': 'Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Q1_Follow-up 2 Day 35', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}, {'title': 'Q2_Follow-up 2 Day 35', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}, {'title': 'Q3_Follow-up 2 Day 35', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'Q4_Follow-up 2 Day 35', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}, {'title': 'Q5_Follow-up 2 Day 35', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Q6_Follow-up 2 Day 35', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}, {'title': 'Q7_Follow-up 1 Day 35', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}]}, {'title': 'Q8_Follow-up 2 Day 35', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35)', 'description': 'Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.'}, {'type': 'SECONDARY', 'title': 'Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Baseline_Period 1', 'categories': [{'measurements': [{'value': '2.50', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '2.10', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '2.40', 'spread': '0.82', 'groupId': 'OG003'}]}]}, {'title': 'Follow-up 1_Day 14', 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '2.00', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '2.28', 'spread': '0.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)', 'description': 'SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Baseline_Period 2', 'categories': [{'measurements': [{'value': '1.56', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '1.67', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '1.84', 'spread': '0.90', 'groupId': 'OG003'}]}]}, {'title': 'Follow-Up 2_Day 35', 'categories': [{'measurements': [{'value': '1.50', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '2.24', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '1.59', 'spread': '1.33', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)', 'description': 'SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation and Systane®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Comfort_Prefer New Eye Drop Formulation', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Comfort_Prefer Systane®', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Comfort_Prefer Neither', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Symptom Relief_Prefer New Eye Drop Formulation', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Symptom Relief_Prefer Systane®', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Symptom Relief_Prefer Neither', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Less blurring_Prefer New Eye Drop Formulation', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Less blurring_Prefer Systane®', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Less blurring_Prefer Neither', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Purchase_Prefer New Eye Drop Formulation', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Purchase_Prefer Systane®', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Purchase_Prefer Neither', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 35', 'description': 'End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 3 participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation and Genteal®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Genteal® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Comfort_Prefer New Eye Drop Formulation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Comfort_Prefer Genteal®', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Comfort_Prefer Neither', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Symptom Relief_Prefer New Eye Drop Formulation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Symptom Relief_Prefer Genteal®', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Symptom Relief_Prefer Neither', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Less blurring_Prefer New Eye Drop Formulation', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Less blurring_Prefer Genteal®', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Less blurring_Prefer Neither', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Purchase_Prefer New Eye Drop Formulation', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Purchase_Prefer Genteal®', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Purchase_Prefer Neither', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 35', 'description': 'End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 6 participants.'}, {'type': 'SECONDARY', 'title': 'Distance Visual Acuity in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Right Eye (OD)_Follow-Up 1 Day 14_5 Min', 'categories': [{'measurements': [{'value': '46.05', 'spread': '9.00', 'groupId': 'OG000'}, {'value': '46.28', 'spread': '6.13', 'groupId': 'OG001'}, {'value': '49.00', 'spread': '5.98', 'groupId': 'OG002'}, {'value': '47.44', 'spread': '6.22', 'groupId': 'OG003'}]}]}, {'title': 'OD_Follow-Up 1 Day 14_30 Min', 'categories': [{'measurements': [{'value': '47.32', 'spread': '8.84', 'groupId': 'OG000'}, {'value': '50.78', 'spread': '4.58', 'groupId': 'OG001'}, {'value': '51.05', 'spread': '4.49', 'groupId': 'OG002'}, {'value': '48.94', 'spread': '6.40', 'groupId': 'OG003'}]}]}, {'title': 'Left Eye (OS)_Follow-Up 1 Day 14_5 Min', 'categories': [{'measurements': [{'value': '45.84', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '47.39', 'spread': '4.09', 'groupId': 'OG001'}, {'value': '49.79', 'spread': '5.63', 'groupId': 'OG002'}, {'value': '47.78', 'spread': '5.06', 'groupId': 'OG003'}]}]}, {'title': 'OS_Follow-Up 1 Day 14_30 Min', 'categories': [{'measurements': [{'value': '47.53', 'spread': '8.59', 'groupId': 'OG000'}, {'value': '48.44', 'spread': '4.48', 'groupId': 'OG001'}, {'value': '50.21', 'spread': '5.68', 'groupId': 'OG002'}, {'value': '50.94', 'spread': '4.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation', 'description': 'Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).', 'unitOfMeasure': 'Letters Read Correctly', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Distance Visual Acuity in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'OD_Follow-Up 2 Day 35_5 Min', 'categories': [{'measurements': [{'value': '48.56', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '46.56', 'spread': '6.51', 'groupId': 'OG001'}, {'value': '47.35', 'spread': '5.70', 'groupId': 'OG002'}, {'value': '48.65', 'spread': '5.44', 'groupId': 'OG003'}]}]}, {'title': 'OD_Follow-Up 2 Day 35_30 Min', 'categories': [{'measurements': [{'value': '51.00', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '51.11', 'spread': '5.47', 'groupId': 'OG001'}, {'value': '50.35', 'spread': '5.58', 'groupId': 'OG002'}, {'value': '51.94', 'spread': '3.49', 'groupId': 'OG003'}]}]}, {'title': 'OS_Follow-Up 2 Day 35_5 Min', 'categories': [{'measurements': [{'value': '48.11', 'spread': '6.11', 'groupId': 'OG000'}, {'value': '47.11', 'spread': '6.28', 'groupId': 'OG001'}, {'value': '46.47', 'spread': '7.22', 'groupId': 'OG002'}, {'value': '49.71', 'spread': '4.87', 'groupId': 'OG003'}]}]}, {'title': 'OS_Follow-Up 2 Day 35_30 Min', 'categories': [{'measurements': [{'value': '51.11', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '49.11', 'spread': '5.68', 'groupId': 'OG001'}, {'value': '49.35', 'spread': '6.01', 'groupId': 'OG002'}, {'value': '51.24', 'spread': '3.58', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation', 'description': 'Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).', 'unitOfMeasure': 'Letters Read Correctly', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.'}, {'type': 'SECONDARY', 'title': 'Tear Break-Up Time With Fluorescein in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Right Eye (OD)_Follow-Up 1 Day 14_5 Min', 'categories': [{'measurements': [{'value': '5.17', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '4.99', 'spread': '1.86', 'groupId': 'OG002'}, {'value': '4.27', 'spread': '1.03', 'groupId': 'OG003'}]}]}, {'title': 'OD_Follow-Up 1 Day 14_30 Min', 'categories': [{'measurements': [{'value': '6.21', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '5.24', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '4.86', 'spread': '1.81', 'groupId': 'OG002'}, {'value': '5.00', 'spread': '1.70', 'groupId': 'OG003'}]}]}, {'title': 'Left Eye (OS)_Follow-Up 1 Day 14_5 Min', 'categories': [{'measurements': [{'value': '5.20', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '5.39', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '5.29', 'spread': '1.91', 'groupId': 'OG002'}, {'value': '4.36', 'spread': '1.30', 'groupId': 'OG003'}]}]}, {'title': 'OS_Follow-Up 1 Day 14_30 Min', 'categories': [{'measurements': [{'value': '6.25', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '5.44', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '4.89', 'spread': '1.61', 'groupId': 'OG002'}, {'value': '4.56', 'spread': '1.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation', 'description': 'Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Tear Break-Up Time With Fluorescein in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'OD_Follow-Up 2 Day 35_ 5 Min', 'categories': [{'measurements': [{'value': '6.31', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '6.13', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '4.93', 'spread': '1.97', 'groupId': 'OG002'}, {'value': '5.63', 'spread': '3.49', 'groupId': 'OG003'}]}]}, {'title': 'OD_Follow-Up 2 Day 35_30 Min', 'categories': [{'measurements': [{'value': '5.68', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '6.34', 'spread': '3.00', 'groupId': 'OG001'}, {'value': '4.94', 'spread': '1.28', 'groupId': 'OG002'}, {'value': '5.22', 'spread': '2.18', 'groupId': 'OG003'}]}]}, {'title': 'OS_Follow-Up 2 Day 35_5 Min', 'categories': [{'measurements': [{'value': '5.64', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '2.54', 'groupId': 'OG001'}, {'value': '4.88', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '4.74', 'spread': '2.04', 'groupId': 'OG003'}]}]}, {'title': 'OS_Follow-Up 2 Day 35_30 Min', 'categories': [{'measurements': [{'value': '6.06', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '6.01', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '5.18', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '4.65', 'spread': '1.27', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation', 'description': 'Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.'}, {'type': 'SECONDARY', 'title': 'Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Q1 Follow-up 1 Day 14_5 Minutes (Min)', 'categories': [{'measurements': [{'value': '3.32', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '3.58', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '3.17', 'spread': '0.92', 'groupId': 'OG003'}]}]}, {'title': 'Q2 Follow-up 1 Day 14_5 Min', 'categories': [{'measurements': [{'value': '3.53', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '3.78', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '3.68', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '3.72', 'spread': '0.67', 'groupId': 'OG003'}]}]}, {'title': 'Q3 Follow-up 1 Day 14_5 Min', 'categories': [{'measurements': [{'value': '3.74', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '3.89', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '3.83', 'spread': '0.86', 'groupId': 'OG003'}]}]}, {'title': 'Q4 Follow-up 1 Day 14_5 Min', 'categories': [{'measurements': [{'value': '26.89', 'spread': '33.95', 'groupId': 'OG000'}, {'value': '20.44', 'spread': '39.04', 'groupId': 'OG001'}, {'value': '21.11', 'spread': '27.23', 'groupId': 'OG002'}, {'value': '28.61', 'spread': '23.20', 'groupId': 'OG003'}]}]}, {'title': 'Q1 Follow-up 1 Day 14_30 Min', 'categories': [{'measurements': [{'value': '3.84', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '3.79', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '4.28', 'spread': '0.83', 'groupId': 'OG003'}]}]}, {'title': 'Q2 Follow-up 1 Day 14_30 Min', 'categories': [{'measurements': [{'value': '3.89', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '4.00', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '4.17', 'spread': '0.38', 'groupId': 'OG003'}]}]}, {'title': 'Q3 Follow-up 1 Day 14_30 Min', 'categories': [{'measurements': [{'value': '3.47', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '2.84', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '3.72', 'spread': '1.07', 'groupId': 'OG003'}]}]}, {'title': 'Q4 Follow-up 1 Day 14_30 Min', 'categories': [{'measurements': [{'value': '30.05', 'spread': '34.98', 'groupId': 'OG000'}, {'value': '43.17', 'spread': '26.18', 'groupId': 'OG001'}, {'value': '28.42', 'spread': '26.05', 'groupId': 'OG002'}, {'value': '48.06', 'spread': '21.70', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation', 'description': 'Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'New Eye Drop Formulation (Systane® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG001', 'title': 'Systane®', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'OG002', 'title': 'New Eye Drop Formulation (Genteal® Group)', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}, {'id': 'OG003', 'title': 'Genteal®', 'description': '1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.'}], 'classes': [{'title': 'Q1 Follow-up 2 Day 35 _5 Min', 'categories': [{'measurements': [{'value': '3.22', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '3.22', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '3.82', 'spread': '0.81', 'groupId': 'OG002'}, {'value': '3.76', 'spread': '0.83', 'groupId': 'OG003'}]}]}, {'title': 'Q2 Follow-up 2 Day 35_5 Min', 'categories': [{'measurements': [{'value': '3.67', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '3.28', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '3.94', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '3.82', 'spread': '0.81', 'groupId': 'OG003'}]}]}, {'title': 'Q3 Follow-up 2 Day 35_5 Min', 'categories': [{'measurements': [{'value': '3.72', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '3.88', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '4.00', 'spread': '0.61', 'groupId': 'OG003'}]}]}, {'title': 'Q4 Follow-up 2 Day 35_5 Min', 'categories': [{'measurements': [{'value': '26.89', 'spread': '29.66', 'groupId': 'OG000'}, {'value': '18.00', 'spread': '40.11', 'groupId': 'OG001'}, {'value': '38.47', 'spread': '19.01', 'groupId': 'OG002'}, {'value': '40.06', 'spread': '30.92', 'groupId': 'OG003'}]}]}, {'title': 'Q1 Follow-up 2 Day 35_30 Min', 'categories': [{'measurements': [{'value': '4.11', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '4.24', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '3.88', 'spread': '1.05', 'groupId': 'OG003'}]}]}, {'title': 'Q2 Follow-up 2 Day 35_30 Min', 'categories': [{'measurements': [{'value': '3.83', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '4.24', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '4.00', 'spread': '1.06', 'groupId': 'OG003'}]}]}, {'title': 'Q3 Follow-up 2 Day 35_30 Min', 'categories': [{'measurements': [{'value': '3.89', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '3.89', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '4.29', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '4.06', 'spread': '1.09', 'groupId': 'OG003'}]}]}, {'title': 'Q4 Follow-up 2 Day 35_30 Min', 'categories': [{'measurements': [{'value': '33.11', 'spread': '26.87', 'groupId': 'OG000'}, {'value': '26.00', 'spread': '36.84', 'groupId': 'OG001'}, {'value': '47.41', 'spread': '22.89', 'groupId': 'OG002'}, {'value': '52.94', 'spread': '38.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation', 'description': 'Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'New Eye Drop Formulation Then Systane®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'FG001', 'title': 'Systane® Then New Eye Drop Formulation', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'FG002', 'title': 'New Eye Drop Formulation Then Genteal®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'FG003', 'title': 'Genteal® Then New Eye Drop Formulation', 'description': '1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'New Eye Drop Formulation Then Systane®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'BG001', 'title': 'Systane® Then New Eye Drop Formulation', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'BG002', 'title': 'New Eye Drop Formulation Then Genteal®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'BG003', 'title': 'Genteal® Then New Eye Drop Formulation', 'description': '1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.20', 'spread': '13.41', 'groupId': 'BG000'}, {'value': '41.79', 'spread': '15.86', 'groupId': 'BG001'}, {'value': '40.70', 'spread': '11.65', 'groupId': 'BG002'}, {'value': '45.05', 'spread': '17.05', 'groupId': 'BG003'}, {'value': '42.95', 'spread': '14.45', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2015-01-22', 'resultsFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2015-05-22', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-07', 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14)', 'description': 'Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).'}, {'measure': 'Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35)', 'description': 'Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).'}], 'secondaryOutcomes': [{'measure': 'Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1', 'timeFrame': 'Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)', 'description': 'The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.'}, {'measure': 'Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2', 'timeFrame': 'Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)', 'description': 'The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.'}, {'measure': 'Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14)', 'description': 'Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.'}, {'measure': 'Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35)', 'description': 'Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.'}, {'measure': 'Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1', 'timeFrame': 'Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)', 'description': 'SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).'}, {'measure': 'Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2', 'timeFrame': 'Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)', 'description': 'SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).'}, {'measure': 'Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)', 'timeFrame': 'Day 35', 'description': 'End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.'}, {'measure': 'Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)', 'timeFrame': 'Day 35', 'description': 'End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.'}, {'measure': 'Distance Visual Acuity in Period 1', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation', 'description': 'Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).'}, {'measure': 'Distance Visual Acuity in Period 2', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation', 'description': 'Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).'}, {'measure': 'Tear Break-Up Time With Fluorescein in Period 1', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation', 'description': 'Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.'}, {'measure': 'Tear Break-Up Time With Fluorescein in Period 2', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation', 'description': 'Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.'}, {'measure': 'Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1', 'timeFrame': 'After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation', 'description': 'Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.'}, {'measure': 'Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2', 'timeFrame': 'After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation', 'description': 'Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current use of an artificial tear product\n* Visual Acuity of at least 20/40 (while wearing glasses, if necessary).\n\nExclusion Criteria:\n\n* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study\n* Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy within 6 months\n* Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months\n* Diagnosis of glaucoma.'}, 'identificationModule': {'nctId': 'NCT02455050', 'briefTitle': 'A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief', 'nctIdAliases': ['NCT02343900'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '11193X-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'New Eye Drop Formulation then Systane®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks.', 'interventionNames': ['Drug: Carboxymethylcellulose Sodium Based Eye Drops', 'Drug: Systane® Gel Drops']}, {'type': 'OTHER', 'label': 'Systane® then New Eye Drop Formulation', 'description': '1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks.', 'interventionNames': ['Drug: Carboxymethylcellulose Sodium Based Eye Drops', 'Drug: Systane® Gel Drops']}, {'type': 'OTHER', 'label': 'Genteal® then New Eye Drop Formulation', 'description': '1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks.', 'interventionNames': ['Drug: Carboxymethylcellulose Sodium Based Eye Drops', 'Drug: Genteal® Lubricant Gel Drops']}, {'type': 'OTHER', 'label': 'New Eye Drop Formulation then Genteal®', 'description': '1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks.', 'interventionNames': ['Drug: Carboxymethylcellulose Sodium Based Eye Drops', 'Drug: Genteal® Lubricant Gel Drops']}], 'interventions': [{'name': 'Carboxymethylcellulose Sodium Based Eye Drops', 'type': 'DRUG', 'description': '1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \\[New Eye Drop Formula\\] in each eye.', 'armGroupLabels': ['Genteal® then New Eye Drop Formulation', 'New Eye Drop Formulation then Genteal®', 'New Eye Drop Formulation then Systane®', 'Systane® then New Eye Drop Formulation']}, {'name': 'Systane® Gel Drops', 'type': 'DRUG', 'otherNames': ['1 to 2 drops of Systane® Gel Drops in each eye daily.'], 'description': '1 to 2 drops of Systane® Gel Drops in each eye.', 'armGroupLabels': ['New Eye Drop Formulation then Systane®', 'Systane® then New Eye Drop Formulation']}, {'name': 'Genteal® Lubricant Gel Drops', 'type': 'DRUG', 'description': '1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.', 'armGroupLabels': ['Genteal® then New Eye Drop Formulation', 'New Eye Drop Formulation then Genteal®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Azusa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}