Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-01 @ 2:18 AM
Study NCT ID:
NCT00770133
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2008-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of 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': 'D007665', 'term': 'Ketotifen'}, {'id': 'D009278', 'term': 'Naphazoline'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susan.harris@bauschhealth.com', 'phone': '908-300-9920', 'title': 'Study Director', 'organization': 'Bausch Health'}, 'certainAgreement': {'otherDetails': 'Contact sponsor directly for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '14 days', 'eventGroups': [{'id': 'EG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'OG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'classes': [{'title': '3 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '1.81', 'spread': '0.88', 'groupId': 'OG003'}]}]}, {'title': '5 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '1.67', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '1.96', 'spread': '0.94', 'groupId': 'OG003'}]}]}, {'title': '7 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '1.84', 'spread': '1.01', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 5, and 7 minutes post challenge at 14 days', 'description': 'Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment.'}, {'type': 'PRIMARY', 'title': 'Conjunctival Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'OG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'classes': [{'title': '7 minutes post-challeng', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '1.63', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '2.06', 'spread': '0.77', 'groupId': 'OG003'}]}]}, {'title': '15 minutes post-challenge', 'categories': [{'measurements': [{'value': '1.13', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '1.69', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '2.26', 'spread': '0.78', 'groupId': 'OG003'}]}]}, {'title': '20 minutes post-challenge', 'categories': [{'measurements': [{'value': '1.13', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '1.57', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '2.18', 'spread': '0.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment.'}, {'type': 'SECONDARY', 'title': 'Ciliary Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'OG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'classes': [{'title': '7 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': '15 minutes post-challenge', 'categories': [{'measurements': [{'value': '1.05', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '1.59', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': '20 minutes post-challenge', 'categories': [{'measurements': [{'value': '1.04', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '0.92', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.'}, {'type': 'SECONDARY', 'title': 'Episcleral Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'OG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'classes': [{'title': '7 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '1.65', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': '15 minutes post-challenge', 'categories': [{'measurements': [{'value': '1.17', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '1.68', 'spread': '0.94', 'groupId': 'OG002'}]}]}, {'title': '20 minutes post-challenge', 'categories': [{'measurements': [{'value': '1.15', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '0.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.'}, {'type': 'SECONDARY', 'title': 'Chemosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'OG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'classes': [{'title': '7 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.40', 'groupId': 'OG002'}]}]}, {'title': '15 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '0.55', 'groupId': 'OG002'}]}]}, {'title': '20 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '0.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.'}, {'type': 'SECONDARY', 'title': 'Eyelid Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'OG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'classes': [{'title': '7 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': '15 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': '20 minutes post-challenge', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Lid swelling was evaluated by the participant at 7, 15, and 20 minutes post challenge on a 0-3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0=None and 3.0=Severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Eyes With hTearing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'OG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'classes': [{'title': '7 minutes post-challenge', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': '15 minutes post-challenge', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': '20 minutes post-challenge', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Eyes With Ocular Mucus Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'OG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'classes': [{'title': '7 minutes post-challenge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '15 minutes post-challenge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '20 minutes post-challenge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'FG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'FG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'FG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'There were 70 eyes in the KetoNaph group, 72 in the ketotifen group, 70 in the naphazoline group, and 70 in the vehicle group, for a total of 282 eyes (141 subjects).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketotifen/Naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.'}, {'id': 'BG001', 'title': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nKetotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.'}, {'id': 'BG002', 'title': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nNaphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.'}, {'id': 'BG003', 'title': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.\n\nVehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '71'}, {'value': '40.7', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '71'}, {'value': '38.2', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '76'}, {'value': '38.4', 'groupId': 'BG003', 'lowerLimit': '16', 'upperLimit': '76'}, {'value': '38.4', 'groupId': 'BG004', 'lowerLimit': '15', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2011-04-26', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2008-10-08', 'dispFirstSubmitQcDate': '2011-04-26', 'resultsFirstSubmitDate': '2020-08-24', 'studyFirstSubmitQcDate': '2008-10-08', 'dispFirstPostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2008-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching', 'timeFrame': '3, 5, and 7 minutes post challenge at 14 days', 'description': 'Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub'}, {'measure': 'Conjunctival Redness', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.'}], 'secondaryOutcomes': [{'measure': 'Ciliary Redness', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.'}, {'measure': 'Episcleral Redness', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.'}, {'measure': 'Chemosis', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.'}, {'measure': 'Eyelid Swelling', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Lid swelling was evaluated by the participant at 7, 15, and 20 minutes post challenge on a 0-3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0=None and 3.0=Severe.'}, {'measure': 'Percentage of Eyes With hTearing', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present.'}, {'measure': 'Percentage of Eyes With Ocular Mucus Discharge', 'timeFrame': '7, 15, and 20 minutes post challenge at 14 days', 'description': 'Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.\n* Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.\n* Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.\n* Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.\n\nExclusion Criteria:\n\n* Known contraindications or sensitivities to the study medication or its components.\n* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.\n* Use of disallowed medications during the period indicated prior to study enrollment or during the study.'}, 'identificationModule': {'nctId': 'NCT00770133', 'briefTitle': 'Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.', 'orgStudyIdInfo': {'id': '572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketotifen/naphazoline', 'description': 'Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.', 'interventionNames': ['Drug: Ketotifen/naphazoline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.', 'interventionNames': ['Drug: Vehicle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naphazoline', 'description': 'Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.', 'interventionNames': ['Drug: Naphazoline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketotifen', 'description': 'Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.', 'interventionNames': ['Drug: Ketotifen']}], 'interventions': [{'name': 'Ketotifen/naphazoline', 'type': 'DRUG', 'description': 'One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.', 'armGroupLabels': ['Ketotifen/naphazoline']}, {'name': 'Naphazoline', 'type': 'DRUG', 'description': 'One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.', 'armGroupLabels': ['Naphazoline']}, {'name': 'Ketotifen', 'type': 'DRUG', 'description': 'One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.', 'armGroupLabels': ['Ketotifen']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'One drop of vehicle ophthalmic solution at visit 3 and visit 4.', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01845', 'city': 'North Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Research Consultants, Inc.', 'geoPoint': {'lat': 42.6987, 'lon': -71.13506}}], 'overallOfficials': [{'name': 'Laura Trusso', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}