Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT02436759
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2015-05-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mvelasco@osmotica.com', 'phone': '9088091423', 'title': 'Senior Director of Clinical Operations', 'organization': 'RVL Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of treatment is 6 weeks (42 Days)', 'description': 'Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).', 'eventGroups': [{'id': 'EG000', 'title': 'RVL-1201', 'description': 'RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 20, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 15, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Atrial fibrilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Foreign body sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vitreous detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vital dye staining cornea present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Dictionary Version M'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RVL-1201', 'description': 'RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning'}, {'id': 'OG001', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning'}], 'classes': [{'title': 'Mean LPFT-Day 1 Hour 6', 'categories': [{'measurements': [{'value': '5.2', 'spread': '5.97', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '3.93', 'groupId': 'OG001'}]}]}, {'title': 'Mean LPFT-Day 14 Hour 2', 'categories': [{'measurements': [{'value': '6.4', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '5.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided t-test with treatment as a fixed factor and baseline score as a covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Mean change from Baseline (Day 1, Hour 0) compared with Day 1, Hour 6 and Day 14, Hour 2', 'description': 'LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen).', 'unitOfMeasure': 'Points seen', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: randomized who received at least one dose (total of 140 subjects). Per-Protocol Population (PPP): ITT population with no major protocol deviations (total of 139 subjects). ITT analysis was conducted for the primary endpoint, with Last Observation Carried Forward (LOCF) for missing data.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RVL-1201', 'description': 'RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning'}, {'id': 'OG001', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning'}], 'classes': [{'title': 'Primary Efficacy - Day 1, Hour 6', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.924', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.001', 'groupId': 'OG001'}]}]}, {'title': 'Primary Efficacy - Day 14, Hour 2', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.799', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.975', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose - Day 1, Hour 2', 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.776', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.803', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose - Day 1, Hour 8', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.958', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.771', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose - Day 14, Hour 6', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.856', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.985', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose - Day 14, Hour 8', 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.857', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '1.023', 'groupId': 'OG001'}]}]}, {'title': 'Post Dose - Day 42', 'categories': [{'measurements': [{'value': '1.25', 'spread': '1.036', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '1.020', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Two-sided t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42', 'description': 'MRD is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph.', 'unitOfMeasure': 'Millimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: randomized who received at least one dose (total of 140 subjects). Per-Protocol Population (PPP): ITT population with no major protocol deviations (total of 139 subjects). ITT analysis was conducted for the primary endpoint, with Last Observation Carried Forward (LOCF) for missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RVL-1201', 'description': 'RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Subjects Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Subjects Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Planned sample size approx 150 subjects, 100 subjects in the RVL-1201 group, and 50 in the Vehicle group, to be enrolled at approx 20 clinical sites in the US.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RVL-1201', 'description': 'RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '12.22', 'groupId': 'BG000'}, {'value': '63.2', 'spread': '12.45', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '12.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Median', 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'BG000'}, {'value': '65.5', 'groupId': 'BG001'}, {'value': '67.0', 'groupId': 'BG002'}]}]}, {'title': 'Minimum', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Maximum', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intent to Treat (ITT) Population', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Iris Color OD (right eye) and Iris Color OS (left eye)', 'classes': [{'title': 'OD/OS Blue', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'OD/OS Brown', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'OD/OS Green', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'OD/OS Hazel', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'OD/OS Grey', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'OD/OS Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to Treat (ITT) Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2015-05-04', 'resultsFirstSubmitDate': '2020-09-25', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-25', 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group', 'timeFrame': 'Mean change from Baseline (Day 1, Hour 0) compared with Day 1, Hour 6 and Day 14, Hour 2', 'description': 'LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen).'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye', 'timeFrame': 'Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42', 'description': 'MRD is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acquired Blepharoptosis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.', 'detailedDescription': "Ptosis is experienced by approximately 12% of adults over the age of 50 . It is a unilateral or bilateral abnormal drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscle(s) that elevate the upper eyelid: the levator palpebrae superioris and/or Müller's muscle.\n\nTreatment for acquired ptosis usually involves surgery, with risks of infection, bleeding, over or undercorrection, reduced vision, and lagophthalmos (inability to close the eyelids completely) or mechanical treatment e.g scleral contact lenses with a bar to lift the eyelid, eyelid ptosis crutches attached to glasses, or adhesive tape or putty to affix the upper eyelid to the supraorbital structures.\n\nRVL-201 ophthalmic solution is being developed to provide a reversible pharmacologic option for patients with acquired ptosis who are not candidates for surgery or do not wish to undergo surgery.\n\nThe objective of this study is to evaluate the safety and efficacy of RVL-1201 ophthalmic solution in the treatment of acquired blepharoptosis and to assess the safety and comfort of RVL-1201 ophthalmic solution for an extended dosing period of 6 weeks. Subjects will be randomized (2:1) to one of 2 treatment arms and treated for 42 days:\n\n* RVL-1201 0.1% one full drop in each eye QD in the morning (N = 100)\n* RVL-1201 vehicle (placebo) 1 full drop per eye QD in the morning (N = 50)\n\nEfficacy will be assessed with the LPFT, a validated visual field test using the HVF Analyzer and photographic measurement of MRD (the distance from the pupillary light reflex to the central margin of the upper lid) and PFD (the distance from the upper lid margin to the lower lid margin through the central visual axis). Safety assessment will include bilateral SLE/CFS, measurement of PD from external photographs, dilated ophthalmoscopy/fundus examination, tonometry, Snellen VA using recent correction, vital signs (BP/HR), and collection of adverse events (AEs)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects 18 years of age and older.\n2. Presence of all of the following at Screening :\n\n a. Loss on a reliable LPFT of ≥ 8 points in the top 2 rows (LPFT Eligibility Score); subjects must see at least 9 total points in the top 4 rows (LPFT Total Score).\n\n i. This criteria must be met at both the Visit 1 Hour 0 (V1H0) and Visit 1 Hour 6 (V1H6) LPFT assessments\n\n ii. There must be ≤ 4 points of variance between the V1H0 and the V1H6 LPFT Eligibility Score;; AND\n\n b. The MRD, the distance from the central pupillary light reflex to the central margin of the upper lid, must be ≤ 2 mm (no visible central pupillary light reflex defaults to 0) in the same eye as Inclusion Criterion #2a\n\n AND\n\n c. Snellen visual acuity (VA) of 20/80 or better in the same eye as Inclusion Criteria #2a and #2b.\n3. Presence of all of the following at Baseline:\n\n a. Loss on a reliable LPFT of ≥ 8 points in the top 2 rows (LPFT Eligibility Score) in the same eye as Inclusion Criterion #2a; subjects must see at least 9 total points in the top 4 rows (LPFT Total Score).\n\n i. This criteria must be met at the Visit 2 Hour 0 (V2H0) LPFT assessment. ii. There must be ≤ 4 points of variance between the V1H6 and the V2H0 LPFT Eligibility Score;\n\n AND\n\n b. Marginal Reflex Distance (MRD), the distance from the central pupillary light reflex to the central margin of the upper lid, must be ≤ 2 mm (no visible central pupillary light reflex defaults to 0) in the same eye as Inclusion Criterion #2a;\n\n AND\n\n c. Snellen VA of 20/80 or better in the same eye as Inclusion Criteria #2a and #2b.\n4. Female subjects must be 1 year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.\n5. Able to self-administer study medication or to have the study medication administered by a caregiver throughout the study period.\n6. Subjects must be able to understand and sign an IRB approved informed consent form prior to participation in any study-related procedures.\n\nExclusion Criteria:\n\nIn either eye\n\n1. Congenital ptosis.\n2. Presence of either of the following:\n\n 1. Pseudoptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin) or\n 2. Dermatochalasis that extends less than 3 mm above the upper eyelid margin.\n3. Horner syndrome.\n4. Marcus Gunn jaw winking syndrome.\n5. Myasthenia gravis.\n6. Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.\n7. Previous ptosis surgery (previous blepharoplasty \\[only\\] is allowed provided the surgery took place \\> 3 months prior to Visit 1).\n8. Lid position affected by lid or conjunctival scarring.\n9. Visual field loss from any cause other than ptosis.\n10. History of herpes keratitis.\n11. History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed \\> 3 months prior to Visit 1).\n12. Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to Visit 1 and during the study.\n13. Topical application of bimatoprost (ie, Latisse®) to the eyelashes within 7 days prior to Visit 1 and during the study.\n14. Use of topical ophthalmic medications (including anti-allergy \\[eg, antihistamines\\], dry eye \\[ie, Restasis®\\] and anti-inflammatory drugs \\[including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids\\] other than the assigned study medication within 7 days prior to Visit 1 and during the study. Topical ophthalmic prostaglandin analogues for the treatment of elevated intraocular pressure are permitted if dosed in the evening in accordance with the approved prescribing information. All other topical antiglaucoma medications are prohibited\n15. Intravitreal injections (eg, Lucentis®, Eylea®, Avastin®, Triesence®) within 7 days prior to Visit 1 and during the study.\n16. Current punctal plugs or placement of punctal plugs during the study.\n17. Use of over the counter (OTC) vasoconstrictor/decongestant eye medication (eg, Visine® L.R.®) or any ophthalmic or non-ophthalmic α adrenergic agonist including OTC products (eg, Afrin®) at any time during the study; nonpreserved artificial tears are allowed.\n\n General\n18. Resting heart rate (HR) outside the normal range (60-100 beats per minute).\n19. Hypertension with resting diastolic blood pressure (BP) \\> 105 mm Hg.\n20. Use of monoamine oxidase inhibitors (MAOIs; eg, isocarboxazid, phenelzine, tranylcypromine) within 14 days prior to Visit 1 and during the study.\n21. Advanced arteriosclerotic disease or history of cerebrovascular accident (CVA).\n22. History of hyperthyroidism or thyroid eye disease (ie, exophthalmos, upper eyelid retraction, diplopia secondary to extraocular muscle involvement). Hypothyroidism that is controlled on medication is allowed.\n23. Patients with diabetic retinopathy may not be enrolled. However, patients with insulin dependent diabetes, diabetes requiring oral hypoglycemic drugs, or diet controlled diabetes are allowed.\n24. Pregnancy or lactation.\n25. Diagnosed benign prostatic hypertrophy requiring medicinal therapy; previous prostatectomy is allowed.\n26. History of contact or systemic allergic reaction to oxymetazoline or other sympathomimetic drugs (eg, phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, fepradinol, or methoxamine).'}, 'identificationModule': {'nctId': 'NCT02436759', 'briefTitle': 'Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'RVL Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis', 'orgStudyIdInfo': {'id': 'RVL-1201-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RVL-1201', 'description': 'RVL-1201 Ophthalmic Solution 0.1% 1 drop per eye QD for 6 weeks', 'interventionNames': ['Drug: RVL-1201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'RVL-1201 Vehicle Placebo', 'description': 'RVL-1201 Ophthalmic Solution vehicle (placebo) 1 drop per eye QD for 6 weeks', 'interventionNames': ['Drug: RVL-1201 Vehicle Placebo']}], 'interventions': [{'name': 'RVL-1201', 'type': 'DRUG', 'otherNames': ['Oxymetazoline Hydrochloride Ophthalmic Solution 0.1%'], 'description': 'RVL-1201 Ophthalmic Solution 0.1%', 'armGroupLabels': ['RVL-1201']}, {'name': 'RVL-1201 Vehicle Placebo', 'type': 'DRUG', 'otherNames': ['RVL-1201 Ophthalmic Solution 0.1% Placebo'], 'description': 'RVL-1201 Vehicle Placebo', 'armGroupLabels': ['RVL-1201 Vehicle Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33773', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '66204', 'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Chuck Slonim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oculos Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RVL Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}