NCT00443924

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Hypertension
• Open Angle Glaucoma

Interventions

Type	Name	Description
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
DRUG	Placebo	One drop of placebo in each eye every 12 hours for three days
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
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
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

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-03-07
• Last updated: 2015-01-21