Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma
Phase 1
Completed
- Conditions
- Ocular HypertensionOpen Angle Glaucoma
- Interventions
- Drug: PlaceboDrug: INS115644 Ophthalmic Solution
- Registration Number
- NCT00443924
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma
- Have best corrected visual acuity in both eyes of at least +0.5 or better
- Have normal endothelial cell counts and morphology
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Exclusion Criteria
- Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma
- Have a history of any type of intraocular surgery, except for cataract surgery
- Have had cataract surgery within three months
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Arm 1 2 INS115644 Ophthalmic Solution Arm 2 3 INS115644 Ophthalmic Solution Arm 3 4 INS115644 Ophthalmic Solution Arm 4 5 INS115644 Ophthalmic Solution Arm 5
- Primary Outcome Measures
Name Time Method Safety and tolerability 28 days Changes in intraocular pressure 28 days
- Secondary Outcome Measures
Name Time Method