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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00443924
First received: March 5, 2007
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Ocular Hypertension
Open Angle Glaucoma
 Drug: INS115644 Ophthalmic Solution
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Changes in intraocular pressure [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: March 2007
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Arm 1
 Drug: Placebo
One drop of placebo in each eye every 12 hours for three days
Experimental: 2
Arm 2
 Drug: INS115644 Ophthalmic Solution
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
Experimental: 3
Arm 3
 Drug: INS115644 Ophthalmic Solution
One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
Experimental: 4
Arm 4
 Drug: INS115644 Ophthalmic Solution
One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
Experimental: 5
Arm 5
 Drug: INS115644 Ophthalmic Solution
One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443924

Locations
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Ophthalmic Research Associates, Inc.
North Andover, Massachusetts, United States, 01845
United States, New York
Glaucoma Associates of New York
New York, New York, United States, 10003
Glaucoma Associates of New York
New York, New York, United States, 10022
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Mike Schiewe, Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00443924     History of Changes
Other Study ID Numbers: 032-101, P08645
Study First Received: March 5, 2007
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Bilateral ocular hypertension or early primary open angle glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
 Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013