Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT01732757
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2012-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With 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': 'D000069605', 'term': 'Olopatadine Hydrochloride'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D065346', 'term': 'Lubricant Eye Drops'}], 'ancestors': [{'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'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'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': 'D054327', 'term': 'Lubricants'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'spread': '0.582', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.752', 'groupId': 'OG001'}, {'value': '2.00', 'spread': '1.109', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 at 3 Minutes Post Challenge', 'description': 'Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '5 Minutes', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.663', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.725', 'groupId': 'OG001'}, {'value': '2.08', 'spread': '1.061', 'groupId': 'OG002'}]}]}, {'title': '7 Minutes', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.724', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.774', 'groupId': 'OG001'}, {'value': '1.89', 'spread': '1.114', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '3 Minutes', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}, {'value': '65.4', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}]}]}, {'title': '5 Minutes', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}]}]}, {'title': '7 Minutes', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}, {'value': '61.5', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score \\<1.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '3 Minutes', 'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}, {'value': '26.9', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}]}]}, {'title': '5 Minutes', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '26.9', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}]}]}, {'title': '7 Minutes', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '32.7', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '34.3', 'groupId': 'OG001'}, {'value': '8.7', 'groupId': 'OG002'}]}]}, {'title': '0.5', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '10.9', 'groupId': 'OG002'}]}]}, {'title': '1.0', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}]}]}, {'title': '1.5', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '6.4', 'groupId': 'OG002'}]}]}, {'title': '2.0', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '6.7', 'groupId': 'OG001'}, {'value': '17.9', 'groupId': 'OG002'}]}]}, {'title': '2.5', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '22.8', 'groupId': 'OG002'}]}]}, {'title': '3.0', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '15.1', 'groupId': 'OG002'}]}]}, {'title': '3.5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}]}]}, {'title': '4.0', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '4.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).', 'unitOfMeasure': 'Percentage of Subject Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.887', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '0.867', 'groupId': 'OG001'}, {'value': '2.17', 'spread': '0.731', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.844', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '0.877', 'groupId': 'OG001'}, {'value': '2.17', 'spread': '0.784', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.854', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '0.886', 'groupId': 'OG001'}, {'value': '2.22', 'spread': '0.830', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '1.62', 'spread': '0.889', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.887', 'groupId': 'OG001'}, {'value': '2.10', 'spread': '0.805', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.845', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.912', 'groupId': 'OG001'}, {'value': '2.12', 'spread': '0.832', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '2.06', 'spread': '0.831', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '0.913', 'groupId': 'OG001'}, {'value': '2.13', 'spread': '0.903', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.842', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.815', 'groupId': 'OG001'}, {'value': '2.04', 'spread': '0.755', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.820', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.839', 'groupId': 'OG001'}, {'value': '2.04', 'spread': '0.828', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.837', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '0.874', 'groupId': 'OG001'}, {'value': '2.09', 'spread': '0.837', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.350', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.511', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.576', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.562', 'groupId': 'OG001'}, {'value': '0.76', 'spread': '0.691', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.679', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.634', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.757', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.70', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.78', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}, {'type': 'SECONDARY', 'title': 'Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'OG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'OG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'classes': [{'title': '7 Minutes', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.84', 'groupId': 'OG002'}]}]}, {'title': '15 Minutes', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.93', 'groupId': 'OG002'}]}]}, {'title': '20 Minutes', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score 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 is averaged (i.e., one score per subject). A lower score is indicative of less tearing.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects with data at this time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'FG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'FG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.'}, {'id': 'BG001', 'title': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.'}, {'id': 'BG002', 'title': 'Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'spread': '13.78', 'groupId': 'BG000'}, {'value': '38.7', 'spread': '15.10', 'groupId': 'BG001'}, {'value': '34.7', 'spread': '12.58', 'groupId': 'BG002'}, {'value': '37.2', 'spread': '13.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '70', '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': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2012-11-19', 'resultsFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-27', 'studyFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0 at 3 Minutes Post Challenge', 'description': 'Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.'}], 'secondaryOutcomes': [{'measure': 'Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.'}, {'measure': 'Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score \\<1.'}, {'measure': 'Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.'}, {'measure': 'Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).'}, {'measure': 'Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.'}, {'measure': 'Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.'}, {'measure': 'Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.'}, {'measure': 'Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.'}, {'measure': 'Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.'}, {'measure': 'Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0', 'timeFrame': 'Day 0', 'description': 'Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score 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 is averaged (i.e., one score per subject). A lower score is 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 efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to 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 ocular allergies within the past 24 months.\n* Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.\n\nExclusion Criteria:\n\n* Any presence of active ocular infection or history of an ocular herpetic infection.\n* Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.\n* Have any planned surgery during the study or 30 days after the study.'}, 'identificationModule': {'nctId': 'NCT01732757', 'briefTitle': 'A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'GMA-LAS-12-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lastacaft®', 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.', 'interventionNames': ['Drug: Alcaftadine 0.25%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pataday™', 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.', 'interventionNames': ['Drug: Olopatadine 0.2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)', 'description': 'One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.', 'interventionNames': ['Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%']}], 'interventions': [{'name': 'Alcaftadine 0.25%', 'type': 'DRUG', 'otherNames': ['Lastacaft®'], 'description': 'One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.', 'armGroupLabels': ['Lastacaft®']}, {'name': 'Olopatadine 0.2%', 'type': 'DRUG', 'otherNames': ['Pataday™'], 'description': 'One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.', 'armGroupLabels': ['Pataday™']}, {'name': 'dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%', 'type': 'DRUG', 'otherNames': ['Tears Naturale II'], 'description': 'One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.', 'armGroupLabels': ['Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}