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NCT00443924 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00443924
Other study ID # P08645
Secondary ID 032-101
Status Completed
Phase Phase 1
First received March 5, 2007
Last updated January 19, 2015
Start date March 2007
Est. completion date April 2009

Study information
Verified date January 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability 28 days No
Primary Changes in intraocular pressure 28 days No
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