NCT00523250

Ocular Hypotensive Efficacy of AR-102

A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.

Detailed description

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	AR-102 0.003% Ophthalmic Solution
DRUG	AR-102 0.005% Ophthalmic Solution
DRUG	AR-102 0.01% Ophthalmic Solution
DRUG	AR-102 0.03% Ophthalmic Solution
DRUG	AR-102 Vehicle Ophthalmic Solution

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-08-31
• Last updated: 2014-05-08

Locations

8 sites across 1 country: United States