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Clinical Trials/NCT01789736
NCT01789736
Completed
Phase 2

A Study Assessing the Safety and Ocular Hypotensive Efficacy of PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components

Aerie Pharmaceuticals21 sites in 1 country234 target enrollmentFebruary 2013
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ConditionsOpen Angle GlaucomaOcular Hypertension
InterventionsPG286 Ophthalmic Solution 0.5%AR-12286 Ophthalmic Solution 0.5%Travoprost Ophthalmic Solution 0.004%
DrugsPG286 Ophthalmic Solution 0.5%AR-12286 Ophthalmic Solution 0.5%Travoprost Ophthalmic Solution 0.004%

Overview

Phase
Phase 2
Intervention
PG286 Ophthalmic Solution 0.5%
Conditions
Open Angle Glaucoma
Sponsor
Aerie Pharmaceuticals
Enrollment
234
Locations
21
Primary Endpoint
Mean diurnal IOP
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

In the double-masked, randomized, multi-center, active-controlled parallel study, patients will be randomized to receive either a fixed dose combination of AR-12286 and travoprost, AR-12286, or travoprost. The hypothesis is that there is no difference between each treatment arm.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aerie Pharmaceuticals
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

PG286

PG286 Ophthalmic Solution q.d. O.U.

Intervention: PG286 Ophthalmic Solution 0.5%

AR-12286 Ophthalmic Solution 0.5%

AR-12286 Ophthalmic Solution 0.5% q.d. O.U.

Intervention: AR-12286 Ophthalmic Solution 0.5%

Travoprost 0.004%

Travoprost 0.004% q.d. O.U.

Intervention: Travoprost Ophthalmic Solution 0.004%

Outcomes

Primary Outcomes

Mean diurnal IOP

Time Frame: 28 Days

The primary efficacy endpoint will be the mean diurnal IOP across subjects within treatment group and time point at Day 28.

Secondary Outcomes

  • IOP(7-28 days)

Study Sites (21)

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