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OpenTrials
Completed

NCT Number: NCT00443924

Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open Angle Glaucoma

Age range

18 year–75 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
  • 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

Treatment and study plan

INS115644 Ophthalmic Solution

Drug

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

Placebo

Drug

One drop of placebo in each eye every 12 hours for three days

Primary outcomes

  1. Safety and tolerability

    Time frame: 28 days

  2. Changes in intraocular pressure

    Time frame: 28 days

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 INS115644 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 7, 2007
Registry last updated
Jan 21, 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.

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