NCT01528787

Study of AR-13324 in Patients With Elevated Intraocular Pressure

A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of Three Doses of AR-13324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.

Conditions

• Ocular Hypertension
• Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	AR-13324 Ophthalmic Solution 0.01%	Administered to study eye, once daily (QD) in the morning (AM) for 7 days
DRUG	AR-13324 Ophthalmic Solution 0.02%	Administered to study eye, QD AM for 7 days
DRUG	AR-13324 Ophthalmic Solution 0.04%	Administered to study eye, QD AM for 7 days
OTHER	AR-13324 Ophthalmic Solution Vehicle	Administered to study eye, QD AM for 7 days

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-02-08
• Last updated: 2018-04-18
• Results posted: 2018-02-22

Locations

11 sites across 1 country: United States