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

NCT ID: NCT00767793

Last Updated: 2015-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-05-31

Brief Summary

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

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

One drop in each eye every 12 hours for seven days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One drop in each eye every 12 hours for seven days

Arm 2

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

Group Type EXPERIMENTAL

INS117548

Intervention Type DRUG

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

Arm 3

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

Group Type EXPERIMENTAL

INS117548

Intervention Type DRUG

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

Arm 4

One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Group Type EXPERIMENTAL

INS117548

Intervention Type DRUG

One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Interventions

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Placebo

One drop in each eye every 12 hours for seven days

Intervention Type DRUG

INS117548

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

Intervention Type DRUG

INS117548

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

Intervention Type DRUG

INS117548

One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reza Haque, MD, PhD

Role: STUDY_DIRECTOR

Medical Monitor, Inspire

Other Identifiers

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037-101

Identifier Type: -

Identifier Source: secondary_id

P08650

Identifier Type: -

Identifier Source: org_study_id

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