Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01470118
Status:
COMPLETED
Last Update Posted:
2013-02-21
First Post:
2011-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557708', 'term': 'alcaftadine'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D000069605', 'term': 'Olopatadine Hydrochloride'}, {'id': 'D003911', 'term': 'Dextrans'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D003990', 'term': 'Dibenzoxepins'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', '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': {'description': 'The Safety Population was defined as all randomized subjects who received at least one dose of study treatment and was used to assess adverse events (AEs) and serious adverse events (SAEs).', 'eventGroups': [{'id': 'EG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.', 'otherNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'classes': [{'title': '3 Minutes', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.716', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.8211', 'groupId': 'OG001'}, {'value': '2.14', 'spread': '0.864', 'groupId': 'OG002'}]}]}, {'title': '5 Minutes', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.789', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.852', 'groupId': 'OG001'}, {'value': '2.35', 'spread': '0.759', 'groupId': 'OG002'}]}]}, {'title': '7 Minutes', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.830', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.824', 'groupId': 'OG001'}, {'value': '2.20', 'spread': '0.888', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 Hour 16', 'description': 'Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '1.74', 'spread': '0.612', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '0.709', 'groupId': 'OG001'}, {'value': '2.08', 'spread': '0.605', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '2.01', 'spread': '0.672', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '0.805', 'groupId': 'OG001'}, {'value': '2.22', 'spread': '0.671', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '1.99', 'spread': '0.652', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.870', 'groupId': 'OG001'}, {'value': '2.20', 'spread': '0.691', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 Hour 24', 'description': 'Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.730', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.773', 'groupId': 'OG001'}, {'value': '1.83', 'spread': '0.764', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '1.64', 'spread': '0.805', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.901', 'groupId': 'OG001'}, {'value': '2.00', 'spread': '0.772', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.754', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '0.909', 'groupId': 'OG001'}, {'value': '1.94', 'spread': '0.844', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 Hour 24', 'description': 'Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.667', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '0.827', 'groupId': 'OG001'}, {'value': '2.01', 'spread': '0.682', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.649', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '0.924', 'groupId': 'OG001'}, {'value': '2.15', 'spread': '0.727', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '1.91', 'spread': '0.645', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '0.960', 'groupId': 'OG001'}, {'value': '2.13', 'spread': '0.718', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 Hour 24', 'description': 'Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.392', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.479', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '0.505', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.403', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.616', 'groupId': 'OG001'}, {'value': '1.34', 'spread': '0.668', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '1.14', 'spread': '0.457', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.677', 'groupId': 'OG001'}, {'value': '1.42', 'spread': '0.742', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 Hour 24', 'description': 'Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.75', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.88', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 Hour 24', 'description': 'Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.87', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.86', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 Hour 24', 'description': 'Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}, {'type': 'PRIMARY', 'title': 'Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'classes': [{'title': '3 Minutes', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.807', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.771', 'groupId': 'OG001'}, {'value': '2.27', 'spread': '0.846', 'groupId': 'OG002'}]}]}, {'title': '5 Minutes', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.851', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '0.886', 'groupId': 'OG001'}, {'value': '2.19', 'spread': '0.897', 'groupId': 'OG002'}]}]}, {'title': '7 Minutes', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.911', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.932', 'groupId': 'OG001'}, {'value': '1.96', 'spread': '1.068', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 Hour 24', 'description': 'Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'FG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'FG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'LASTACAFT® (Alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'BG001', 'title': 'Pataday™ (Olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.'}, {'id': 'BG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '12.44', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '14.84', 'groupId': 'BG001'}, {'value': '39.3', 'spread': '12.31', 'groupId': 'BG002'}, {'value': '38.5', 'spread': '13.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-18', 'studyFirstSubmitDate': '2011-11-09', 'resultsFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-18', 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16', 'timeFrame': 'Day 0 Hour 16', 'description': 'Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.'}, {'measure': 'Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24', 'timeFrame': 'Day 14 Hour 24', 'description': 'Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.'}], 'secondaryOutcomes': [{'measure': 'Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'timeFrame': 'Day 14 Hour 24', 'description': 'Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.'}, {'measure': 'Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'timeFrame': 'Day 14 Hour 24', 'description': 'Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.'}, {'measure': 'Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'timeFrame': 'Day 14 Hour 24', 'description': 'Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.'}, {'measure': 'Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'timeFrame': 'Day 14 Hour 24', 'description': 'Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.'}, {'measure': 'Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'timeFrame': 'Day 14 Hour 24', 'description': 'Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.'}, {'measure': 'Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24', 'timeFrame': 'Day 14 Hour 24', 'description': 'Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Conjunctivitis, Allergic']}, 'referencesModule': {'references': [{'pmid': '25260889', 'type': 'DERIVED', 'citation': 'McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA. Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials. Adv Ther. 2014 Oct;31(10):1059-71. doi: 10.1007/s12325-014-0155-3. Epub 2014 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of eye allergies within the past 24 months\n* Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period\n\nExclusion Criteria:\n\n* Current eye infection\n* Eye surgery within 3 months or vision correction surgery within 6 months\n* Any planned surgery during the study or 30 days after the study'}, 'identificationModule': {'nctId': 'NCT01470118', 'briefTitle': 'A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'GMA-LAS-011-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LASTACAFT® (alcaftadine 0.25%)', 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.', 'interventionNames': ['Drug: alcaftadine 0.25% ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pataday™ (olopatadine 0.2%)', 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.', 'interventionNames': ['Drug: olopatadine 0.2% ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)', 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.', 'interventionNames': ['Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%']}], 'interventions': [{'name': 'alcaftadine 0.25% ophthalmic solution', 'type': 'DRUG', 'otherNames': ['LASTACAFT®'], 'description': 'One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.', 'armGroupLabels': ['LASTACAFT® (alcaftadine 0.25%)']}, {'name': 'olopatadine 0.2% ophthalmic solution', 'type': 'DRUG', 'otherNames': ['Pataday™'], 'description': 'One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.', 'armGroupLabels': ['Pataday™ (olopatadine 0.2%)']}, {'name': 'dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%', 'type': 'DRUG', 'otherNames': ['Tears Naturale® II Artificial Tears'], 'description': 'One drop of placebo instilled in each eye at Day 0 and Day 14.', 'armGroupLabels': ['Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}