NCT01123785

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Inotek Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years – 77 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	INO-8875	eye drops for 14 days in one eye
DRUG	Placebo	Matched vehicle-control

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2010-05-14
• Last updated: 2012-10-15

Locations

1 site across 1 country: United States