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Study of AR-13324 in Patients With Elevated Intraocular Pressure

NCT01528787 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-04-18

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Aerie Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Theresa Heah, MD · Aerie Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528787 on ClinicalTrials.gov