A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)

Phase 1CompletedNCT00767793

Merck Sharp & Dohme LLC84 enrolled

Overview

The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Glaucoma

Interventions

PlaceboDRUG

One drop in each eye every 12 hours for seven days

INS117548DRUG

One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

INS117548DRUG

One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: 15

Rate of discontinuation

Time frame: 15

Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters

Time frame: 15

Compliance

Time frame: 15

Data from ClinicalTrials.gov

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