A Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, Pharmacokinetics (PK), and Efficacy of Chronic Topical Ocular Application of INO-8875 in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate how tolerable, safe, and effective it is to give INO-8875 eye drops to adults with glaucoma or ocular hypertension.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inotek Pharmaceuticals Corporation
• Treatments: Adenosine; Ophthalmic Solutions

Criteria

Inclusion Criteria:

1. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).

2. Aged 18 to 75 years.

3. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion Criteria:

1. No significant visual field loss or any new field loss within the past year.

2. Cup-to-disc ratio ≥0.8

3. Central corneal thickness <500 µm or >600 µm

4. History of adult asthma or chronic obstructive pulmonary disease

5. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data