Title
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
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
Phase
Phase 1Lead Sponsor
MerckStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
GlaucomaIntervention/Treatment
pilocarpine ...Study Participants
84The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
One drop in each eye every 12 hours for seven days
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
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
