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 |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | May 2010 |
| End Date: | December 2011 |
| Contact: | Laura Blackburn |
| Email: | blackburnla@me.com |
| Phone: | 508-878-0658 |
A Phase I/II Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics (Efficacy) of Chronic Twice-Daily Topical Monocular Application of INO-8875 Ophthalmic Formulation in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
