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

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

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