Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-30 @ 9:42 AM
Study NCT ID:
NCT04675151
Status:
COMPLETED
Last Update Posted:
2025-10-10
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010862', 'term': 'Pilocarpine'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcoleman@ocuphire.com', 'phone': '8134041993', 'title': 'Drey Coleman', 'organization': 'Ocuphire Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 days.', 'description': 'Data is not provided for each intervention separately as analyses by specific intervention were not conducted.', 'eventGroups': [{'id': 'EG000', 'title': 'POS 0.75% First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 15, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'POS 0.75% First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 6, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'POS Vehicle First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 6, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'POS Vehicle First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 2, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Instillation site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Installation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Installation site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'POS 0.75% First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG001', 'title': 'POS 0.75% First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG002', 'title': 'POS Vehicle First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG003', 'title': 'POS Vehicle First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}, {'value': '27.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2 at 1 hour', 'description': "The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).", 'unitOfMeasure': 'percentage of subjects with ≥ 15 letters', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'POS 0.75% First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG001', 'title': 'POS 0.75% First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG002', 'title': 'POS Vehicle First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG003', 'title': 'POS Vehicle First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}], 'classes': [{'title': '% of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}, {'value': '86.7', 'groupId': 'OG001'}, {'value': '74.2', 'groupId': 'OG002'}, {'value': '70.5', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 10 letters from baseline at 0.5 hours', 'categories': [{'measurements': [{'value': '76.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '54.8', 'groupId': 'OG002'}, {'value': '52.3', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 15 letters from baseline at 0.5 hours', 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '25.8', 'groupId': 'OG002'}, {'value': '15.9', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 5 letters from baseline at 2 hours', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}, {'value': '93.3', 'groupId': 'OG001'}, {'value': '83.9', 'groupId': 'OG002'}, {'value': '70.5', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 10 letters from baseline at 2 hours', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '71.0', 'groupId': 'OG002'}, {'value': '45.5', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 15 letters from baseline at 2 hours', 'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '41.9', 'groupId': 'OG002'}, {'value': '18.2', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 5 letters from baseline at 3 hours', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '83.9', 'groupId': 'OG002'}, {'value': '72.7', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 10 letters from baseline at 3 hours', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '64.5', 'groupId': 'OG002'}, {'value': '43.2', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 15 letters from baseline at 3 hours', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '48.4', 'groupId': 'OG002'}, {'value': '20.5', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 5 letters from baseline at 4 hours', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '83.9', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 10 letters from baseline at 4 hours', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '51.6', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 15 letters from baseline at 4 hours', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '32.3', 'groupId': 'OG002'}, {'value': '20.5', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 5 letters from baseline at 6 hours', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}, {'value': '86.7', 'groupId': 'OG001'}, {'value': '71.0', 'groupId': 'OG002'}, {'value': '72.7', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 10 letters from baseline at 6 hours', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '54.8', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 15 letters from baseline at 6 hours', 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}, {'value': '18.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours', 'description': 'The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours', 'unitOfMeasure': 'percentage of subjects with improvement', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'POS 0.75% First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG001', 'title': 'POS 0.75% First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG002', 'title': 'POS Vehicle First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG003', 'title': 'POS Vehicle First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '41.9', 'groupId': 'OG002'}, {'value': '27.93', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2 at 1 hour', 'description': 'The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with \\< 5 letters of loss in photopic binocular BCDVA from Baseline', 'unitOfMeasure': '% of subjects with improvement', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'POS 0.75% First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG001', 'title': 'POS 0.75% First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG002', 'title': 'POS Vehicle First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'OG003', 'title': 'POS Vehicle First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}], 'classes': [{'title': '% of subjects with improvement of ≥ 5 letters from baseline at 1 hour', 'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000'}, {'value': '46.7', 'groupId': 'OG001'}, {'value': '71.0', 'groupId': 'OG002'}, {'value': '56.8', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 10 letters from baseline at 1 hour', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 15 letters from baseline at 1 hour', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 5 letters from baseline at 3 hours', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '43.3', 'groupId': 'OG001'}, {'value': '67.7', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 10 letters from baseline at 3 hours', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '41.9', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 15 letters from baseline at 3 hours', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 5 letters from baseline at 6 hours', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000'}, {'value': '56.7', 'groupId': 'OG001'}, {'value': '38.7', 'groupId': 'OG002'}, {'value': '47.7', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 10 letters from baseline at 6 hours', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '29.0', 'groupId': 'OG002'}, {'value': '18.2', 'groupId': 'OG003'}]}]}, {'title': '% of subjects with improvement of ≥ 15 letters from baseline at 6 hours', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '12.9', 'groupId': 'OG002'}, {'value': '4.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2 at 1 hour, at 3 hours, and at 6 hours', 'description': 'The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters', 'unitOfMeasure': 'percentage with improvement', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'POS 0.75% First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'FG001', 'title': 'POS 0.75% First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'FG002', 'title': 'POS Vehicle First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'FG003', 'title': 'POS Vehicle First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '148', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'POS 0.75% First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'BG001', 'title': 'POS 0.75% First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'BG002', 'title': 'POS Vehicle First, Then LDP 0.4%', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.\n\nTreatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'BG003', 'title': 'POS Vehicle First, Then LDP Vehicle', 'description': 'Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.\n\nThen, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.\n\nTreatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '5.63', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '5.11', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '5.21', 'groupId': 'BG002'}, {'value': '53.2', 'spread': '4.55', 'groupId': 'BG003'}, {'value': '53.1', 'spread': '5.09', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '138', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study eye, n (%)', 'classes': [{'categories': [{'title': 'OD', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}, {'title': 'OS', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Iris color, n (%)', 'classes': [{'categories': [{'title': 'Light blue', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Dark blue', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Blue with peripupillary brown', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'Uniform green', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Green with brown iris ring', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Central brown and peripheral green', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Brown with some peripheral green', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Brown', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Irides type, n (%)', 'classes': [{'categories': [{'title': 'Light', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}, {'title': 'Dark', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline photopic BCDVA study eye, letters read', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '3.46', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '2.84', 'groupId': 'BG001'}, {'value': '58.1', 'spread': '3.00', 'groupId': 'BG002'}, {'value': '59.2', 'spread': '3.58', 'groupId': 'BG003'}, {'value': '58.3', 'spread': '3.31', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic BCDVA fellow eye', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '3.12', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '3.39', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '3.29', 'groupId': 'BG002'}, {'value': '59.3', 'spread': '3.69', 'groupId': 'BG003'}, {'value': '58.7', 'spread': '3.40', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic BCDVA binocular', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '2.97', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '3.53', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '3.77', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '3.560', 'groupId': 'BG003'}, {'value': '60.9', 'spread': '3.45', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline mesopic BCDVA study eye', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '3.95', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '6.44', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '5.83', 'groupId': 'BG002'}, {'value': '52.2', 'spread': '5.31', 'groupId': 'BG003'}, {'value': '51.0', 'spread': '5.36', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline mesopic BCDVA fellow eye', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '4.11', 'groupId': 'BG000'}, {'value': '50.6', 'spread': '6.53', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '6.14', 'groupId': 'BG002'}, {'value': '52.2', 'spread': '5.06', 'groupId': 'BG003'}, {'value': '51.2', 'spread': '5.38', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline mesopic BCDVA binocular', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '3.31', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '4.93', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '5.44', 'groupId': 'BG002'}, {'value': '54.8', 'spread': '4.98', 'groupId': 'BG003'}, {'value': '54.0', 'spread': '4.68', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic DCNVA study eye', 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'spread': '5.39', 'groupId': 'BG000'}, {'value': '37.9', 'spread': '7.23', 'groupId': 'BG001'}, {'value': '42.8', 'spread': '5.34', 'groupId': 'BG002'}, {'value': '42.0', 'spread': '5.00', 'groupId': 'BG003'}, {'value': '41.3', 'spread': '5.90', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic DCNVA fellow eye', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '4.48', 'groupId': 'BG000'}, {'value': '42.8', 'spread': '6.28', 'groupId': 'BG001'}, {'value': '44.7', 'spread': '4.61', 'groupId': 'BG002'}, {'value': '44.9', 'spread': '4.56', 'groupId': 'BG003'}, {'value': '44.3', 'spread': '4.95', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic DCNVA binocular', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '3.85', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '5.32', 'groupId': 'BG001'}, {'value': '47.6', 'spread': '3.49', 'groupId': 'BG002'}, {'value': '46.1', 'spread': '3.83', 'groupId': 'BG003'}, {'value': '46.3', 'spread': '4.15', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline mesopic DCNVA study eye', 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '7.05', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '6.81', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '6.54', 'groupId': 'BG002'}, {'value': '36.4', 'spread': '6.45', 'groupId': 'BG003'}, {'value': '36.2', 'spread': '6.71', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline mesopic DCNVA fellow eye', 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'spread': '6.59', 'groupId': 'BG000'}, {'value': '37.3', 'spread': '6.92', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '6.35', 'groupId': 'BG002'}, {'value': '37.3', 'spread': '6.70', 'groupId': 'BG003'}, {'value': '37.7', 'spread': '6.59', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline mesopic DCNVA binocular', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '5.99', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '6.36', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '6.41', 'groupId': 'BG002'}, {'value': '40.3', 'spread': '6.05', 'groupId': 'BG003'}, {'value': '40.6', 'spread': '6.13', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read at 4 m distance', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic DCIVA study eye', 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'spread': '6.87', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '8.04', 'groupId': 'BG001'}, {'value': '46.9', 'spread': '6.34', 'groupId': 'BG002'}, {'value': '46.0', 'spread': '6.39', 'groupId': 'BG003'}, {'value': '46.5', 'spread': '6.86', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic DCIVA fellow eye', 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'spread': '6.68', 'groupId': 'BG000'}, {'value': '49.1', 'spread': '7.01', 'groupId': 'BG001'}, {'value': '48.4', 'spread': '5.10', 'groupId': 'BG002'}, {'value': '48.3', 'spread': '6.19', 'groupId': 'BG003'}, {'value': '48.6', 'spread': '6.25', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic DCIVA binocular', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '6.42', 'groupId': 'BG000'}, {'value': '52.6', 'spread': '7.45', 'groupId': 'BG001'}, {'value': '50.9', 'spread': '4.87', 'groupId': 'BG002'}, {'value': '51.5', 'spread': '6.14', 'groupId': 'BG003'}, {'value': '51.5', 'spread': '6.24', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'letters read', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic PD study eye', 'classes': [{'categories': [{'measurements': [{'value': '4.297', 'spread': '0.8347', 'groupId': 'BG000'}, {'value': '4.494', 'spread': '0.8190', 'groupId': 'BG001'}, {'value': '4.342', 'spread': '0.9966', 'groupId': 'BG002'}, {'value': '4.265', 'spread': '0.8782', 'groupId': 'BG003'}, {'value': '4.337', 'spread': '0.8756', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline photopic PD fellow eye', 'classes': [{'categories': [{'measurements': [{'value': '4.267', 'spread': '0.8277', 'groupId': 'BG000'}, {'value': '4.608', 'spread': '0.9048', 'groupId': 'BG001'}, {'value': '4.391', 'spread': '0.9617', 'groupId': 'BG002'}, {'value': '4.340', 'spread': '0.8299', 'groupId': 'BG003'}, {'value': '4.384', 'spread': '0.8731', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline mesopic PD study eye', 'classes': [{'categories': [{'measurements': [{'value': '5.059', 'spread': '0.8747', 'groupId': 'BG000'}, {'value': '5.049', 'spread': '0.7324', 'groupId': 'BG001'}, {'value': '4.992', 'spread': '1.1530', 'groupId': 'BG002'}, {'value': '5.113', 'spread': '0.8310', 'groupId': 'BG003'}, {'value': '5.059', 'spread': '0.8942', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline mesopic PD fellow eye', 'classes': [{'categories': [{'measurements': [{'value': '5.136', 'spread': '0.8759', 'groupId': 'BG000'}, {'value': '5.100', 'spread': '0.6839', 'groupId': 'BG001'}, {'value': '4.996', 'spread': '1.1266', 'groupId': 'BG002'}, {'value': '5.197', 'spread': '0.8201', 'groupId': 'BG003'}, {'value': '5.117', 'spread': '0.8789', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline IOP study eye', 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '3.40', 'groupId': 'BG000'}, {'value': '14.8', 'spread': '3.14', 'groupId': 'BG001'}, {'value': '13.9', 'spread': '2.54', 'groupId': 'BG002'}, {'value': '13.6', 'spread': '2.88', 'groupId': 'BG003'}, {'value': '14.1', 'spread': '3.03', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline IOP fellow eye', 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '2.99', 'groupId': 'BG000'}, {'value': '14.9', 'spread': '2.94', 'groupId': 'BG001'}, {'value': '14.1', 'spread': '2.41', 'groupId': 'BG002'}, {'value': '13.8', 'spread': '2.85', 'groupId': 'BG003'}, {'value': '14.3', 'spread': '2.83', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-30', 'size': 1265202, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-23T10:18', 'hasProtocol': True}, {'date': '2021-06-10', 'size': 1283452, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-22T18:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2020-12-15', 'resultsFirstSubmitDate': '2023-06-23', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-07-17', 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA', 'timeFrame': 'Visit 2 at 1 hour', 'description': "The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1)."}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline', 'timeFrame': 'Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours', 'description': 'The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours'}, {'measure': 'Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline', 'timeFrame': 'Visit 2 at 1 hour', 'description': 'The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with \\< 5 letters of loss in photopic binocular BCDVA from Baseline'}, {'measure': 'Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline', 'timeFrame': 'Visit 2 at 1 hour, at 3 hours, and at 6 hours', 'description': 'The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nyxol', 'Presbyopia', 'Pilocarpine'], 'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are:\n\nTo evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females ≥ 40 and ≤ 64years of age.\n2. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.\n3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.\n4. Subjects who depend on reading glasses or bifocals in which their binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.\n\nExclusion Criteria:\n\nOphthalmic (in either eye):\n\n1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.\n2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion.\n3. Current use of any topical ophthalmic therapy for dry eye.\n4. Tear break-up time of \\< 5 seconds or corneal fluorescein staining.\n5. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.\n6. Recent or current evidence of ocular infection or inflammation in either eye.\n7. Any history of herpes simplex or herpes zoster keratitis.\n8. History of diabetic retinopathy or diabetic macular edema.\n9. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.\n10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.\n11. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.\n12. History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.\n13. Unwilling or unable to discontinue use of contact lenses.\n14. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.\n\n Systemic:\n15. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.\n16. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.\n17. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.\n18. Participation in any investigational study within 30 days prior to Screening.\n19. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.\n20. Resting HR outside the specified range of 50 to 110 beats per minute.\n21. Hypertension with resting diastolic BP \\> 105 mmHg or systolic BP \\> 160 mmHg.'}, 'identificationModule': {'nctId': 'NCT04675151', 'briefTitle': 'Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ocuphire Pharma, Inc.'}, 'officialTitle': 'Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) With Pilocarpine Eye Drops in Subjects With Presbyopia', 'orgStudyIdInfo': {'id': 'OPI-NYXP-201 (VEGA-1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nyxol + Pilocarpine', 'description': '1 drop of Nyxol (Treatment 1) and 1 drop of Pilocarpine (Treatment 2)', 'interventionNames': ['Drug: Phentolamine Ophthalmic Solution 0.75%', 'Drug: Pilocarpine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nyxol', 'description': '1 drop of Nyxol (Treatment 1)', 'interventionNames': ['Drug: Phentolamine Ophthalmic Solution 0.75%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pilocarpine', 'description': '1 drop of Pilocarpine (Treatment 2)', 'interventionNames': ['Drug: Pilocarpine', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 drop of Placebo (Treatment 1)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Phentolamine Ophthalmic Solution 0.75%', 'type': 'DRUG', 'otherNames': ['Nyxol', 'Nyxol®'], 'description': '0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist', 'armGroupLabels': ['Nyxol', 'Nyxol + Pilocarpine']}, {'name': 'Pilocarpine', 'type': 'DRUG', 'description': 'Pilocarpine ophthalmic solution', 'armGroupLabels': ['Nyxol + Pilocarpine', 'Pilocarpine']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Phentolamine Ophthalmic Solution Vehicle'], 'description': 'Topical sterile ophthalmic solution', 'armGroupLabels': ['Pilocarpine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 12', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 6', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '34461', 'city': 'Crystal River', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 13', 'geoPoint': {'lat': 28.90248, 'lon': -82.5926}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 5', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 11', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site 8', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30041', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Site 10', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Clinical Site 3', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '63101', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Site 18', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '12603', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Site 16', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Clinical Site 14', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45701', 'city': 'Athens', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Site 2', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Site 9', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44115', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Site 7', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43065', 'city': 'Powell', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Site 15', 'geoPoint': {'lat': 40.15784, 'lon': -83.07519}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Clinical Site 4', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Site 1', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ocuphire Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}