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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Placebo; Drug: INS115644 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00443924

P08645

032-101

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Arm 1

Treatment:

Drug: Placebo

2

Experimental group

Description:

Arm 2

Treatment:

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

3

Experimental group

Description:

Arm 3

Treatment:

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

4

Experimental group

Description:

Arm 4

Treatment:

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

5

Experimental group

Description:

Arm 5

Treatment:

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution

Drug: INS115644 Ophthalmic Solution