A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS117548 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Glaucoma
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 84
- Primary Endpoint
- Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Arm 1
One drop in each eye every 12 hours for seven days
Intervention: Placebo
Arm 2
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Intervention: INS117548
Arm 3
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Intervention: INS117548
Arm 4
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
Intervention: INS117548
Outcomes
Primary Outcomes
Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
Time Frame: 15
Rate of discontinuation
Time Frame: 15
Incidence of adverse events
Time Frame: 15
Compliance
Time Frame: 15