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

Phase 1

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: Placebo; Drug: INO-8875

• Registration Number: NCT01123785
• Lead Sponsor: Inotek Pharmaceuticals Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-14
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Disposition First Submitted: 2012-04-27
• Status Verified: 2012-10
• Disposition First Submitted QC: 2012-10-11
• Last Update Submitted: 2012-10-11
• Disposition First Posted: 2012-10-15
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Matched vehicle-control
INO-8875	INO-8875	Adenosine agonist eye drop

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	14 days

Secondary Outcome Measures

Name	Time	Method
Number of Participants with decreased Intra-ocular pressure	14 days

Trial Locations

Locations (1)

Lugene Eye Institute; 🇺🇸 Glendale, California, United States