A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Glaucoma

Treatments: Drug: INS117548; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767793

P08650

037-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.

Enrollment: 84 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

One drop in each eye every 12 hours for seven days

Treatment:

Drug: Placebo

Arm 2

Experimental group

Description:

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

Treatment:

Drug: INS117548

Drug: INS117548

Drug: INS117548

Arm 3

Experimental group

Description:

One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Treatment:

Drug: INS117548

Drug: INS117548

Drug: INS117548

Arm 4

Experimental group

Description:

One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days

Treatment:

Drug: INS117548

Drug: INS117548

Drug: INS117548