Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 11:13 PM
Study NCT ID:
NCT00523250
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2007-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Hypotensive Efficacy of AR-102
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'dispFirstSubmitDate': '2014-02-17', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-18', 'studyFirstSubmitDate': '2007-08-30', 'dispFirstSubmitQcDate': '2014-03-25', 'studyFirstSubmitQcDate': '2007-08-30', 'dispFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.', 'timeFrame': 'One week'}], 'secondaryOutcomes': [{'measure': 'The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject questionnaires', 'timeFrame': 'One week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.', 'detailedDescription': 'A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or greater (male, or female not of childbearing potential).\n* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s).\n* Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component of the formulation or to topical anesthetics\n* Previous glaucoma intraocular surgery or laser procedures in study eye(s)\n* Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.\n* Participation in any study involving an investigational drug within the past 30 days.'}, 'identificationModule': {'nctId': 'NCT00523250', 'briefTitle': 'Ocular Hypotensive Efficacy of AR-102', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aerie Pharmaceuticals'}, 'officialTitle': 'A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure', 'orgStudyIdInfo': {'id': 'AR102-CS201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR-102 0.003% Ophthalmic Solution', 'description': 'q.d. ocular', 'interventionNames': ['Drug: AR-102 0.003% Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'AR-102 0.005% Ophthalmic Solution', 'description': 'q.d. ocular', 'interventionNames': ['Drug: AR-102 0.005% Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'AR-102 0.01% Ophthalmic Solution', 'description': 'q.d. ocular', 'interventionNames': ['Drug: AR-102 0.01% Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'AR-102 0.03% Ophthalmic Solution', 'description': 'q.d. ocular', 'interventionNames': ['Drug: AR-102 0.03% Ophthalmic Solution']}, {'type': 'EXPERIMENTAL', 'label': 'AR-102 Vehicle Ophthalmic Solution', 'description': 'q.d. ocular', 'interventionNames': ['Drug: AR-102 Vehicle Ophthalmic Solution']}], 'interventions': [{'name': 'AR-102 0.003% Ophthalmic Solution', 'type': 'DRUG', 'armGroupLabels': ['AR-102 0.003% Ophthalmic Solution']}, {'name': 'AR-102 0.005% Ophthalmic Solution', 'type': 'DRUG', 'armGroupLabels': ['AR-102 0.005% Ophthalmic Solution']}, {'name': 'AR-102 0.01% Ophthalmic Solution', 'type': 'DRUG', 'armGroupLabels': ['AR-102 0.01% Ophthalmic Solution']}, {'name': 'AR-102 0.03% Ophthalmic Solution', 'type': 'DRUG', 'armGroupLabels': ['AR-102 0.03% Ophthalmic Solution']}, {'name': 'AR-102 Vehicle Ophthalmic Solution', 'type': 'DRUG', 'armGroupLabels': ['AR-102 Vehicle Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Soilsh Practice', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'Bacharach practice', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '34613', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': 'Hernando Eye Institute', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Taustine Eye Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mundorf Practice', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Black Hills Regional Eye Institute', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texan Eye', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical Center Ophthalmology Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Thomas Van Haarlem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aerie Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aerie Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}