A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS115644 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma

Merck Sharp & Dohme LLC0 sites56 target enrollmentMarch 2007

ConditionsOcular Hypertension Open Angle Glaucoma

InterventionsPlacebo INS115644 Ophthalmic Solution

DrugsINS115644 Ophthalmic Solution Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Ocular Hypertension
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 56
Primary Endpoint: Safety and tolerability
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

April 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

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
•Have normal endothelial cell counts and morphology

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