Skip to main content
OpenTrials
Completed

NCT Number: NCT00767793

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

One drop in each eye every 12 hours for seven days

INS117548

Drug

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: 15

  2. Rate of discontinuation

    Time frame: 15

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

    Time frame: 15

  4. Compliance

    Time frame: 15

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 7, 2008
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.