CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
AR-13324 Ophthalmic Solution 0.01% +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01528787
NCT01528787Phase 2Completed

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

Aerie Pharmaceuticals·interventional·Posted Feb 8, 2012·Updated Apr 18, 2018

In Brief

A Phase 2 clinical trial evaluating AR-13324 Ophthalmic Solution 0.01%, AR-13324 Ophthalmic Solution 0.02%, and 2 other interventions for Ocular Hypertension and Open Angle Glaucoma. Completed, enrolled 85 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2012
Enrollment StartMar 1, 2012
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.4 years ago

Interventions

AR-13324 Ophthalmic Solution 0.01%drug

Administered to study eye, once daily (QD) in the morning (AM) for 7 days

AR-13324 Ophthalmic Solution 0.02%drug

Administered to study eye, QD AM for 7 days

AR-13324 Ophthalmic Solution 0.04%drug

Administered to study eye, QD AM for 7 days

AR-13324 Ophthalmic Solution Vehicleother

Administered to study eye, QD AM for 7 days