A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
Phase 1
Completed
- Conditions
- Glaucoma
- Interventions
- Drug: INS117548Drug: Placebo
- Registration Number
- NCT00767793
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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
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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 Arm 3 INS117548 One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days Arm 1 Placebo One drop in each eye every 12 hours for seven days Arm 2 INS117548 One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days Arm 4 INS117548 One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
- Primary Outcome Measures
Name Time Method Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters 15 Rate of discontinuation 15 Incidence of adverse events 15 Compliance 15
- Secondary Outcome Measures
Name Time Method