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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT01123785

Run by

Inotek Pharmaceuticals Corporation

People needed

144

Starts

2010-05-01

Expected to finish

2012-01-01

Last updated by the study team

2012-10-15

Who can join

Age: 18 and older, up to 77. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).
• Aged 18 to 75 years.
• Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

You may not qualify if…

• No significant visual field loss or any new field loss within the past year.
• Cup-to-disc ratio ≥0.8
• Central corneal thickness <500 µm or >600 µm
• History of adult asthma or chronic obstructive pulmonary disease
• A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Where it is running

• Lugene Eye Institute — Glendale, California, United States

Full record on ClinicalTrials.gov

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