A Study Assessing PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components for 28 Days

Phase 2

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: PG286 Ophthalmic Solution 0.5%; Drug: AR-12286 Ophthalmic Solution 0.5%; Drug: Travoprost Ophthalmic Solution 0.004%

• Registration Number: NCT01789736
• Lead Sponsor: Aerie Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-09
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-12
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-02
• Disposition First Submitted: 2014-02-17
• Disposition First Submitted QC: 2014-02-17
• Last Update Submitted: 2014-02-17
• Disposition First Posted: 2014-03-17
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PG286	PG286 Ophthalmic Solution 0.5%	PG286 Ophthalmic Solution q.d. O.U.
AR-12286 Ophthalmic Solution 0.5%	AR-12286 Ophthalmic Solution 0.5%	AR-12286 Ophthalmic Solution 0.5% q.d. O.U.
Travoprost 0.004%	Travoprost Ophthalmic Solution 0.004%	Travoprost 0.004% q.d. O.U.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
IOP	7-28 days	Secondary efficacy endpoints will include: mean IOP across subjects within treatment group at each post-treatment timepoint, mean change from diurnally adjusted baseline IOP at each timepoint, mean percent change from diurnally adjusted baseline IOP at each timepoint, mean diurnal IOP at other visits, and mean change from the baseline mean diurnal IOP at each visits.

Trial Locations

Locations (21)

Seidenberg Protzko Eye Associates; 🇺🇸 Havre de Grace, Maryland, United States

Kenneth Sall, M.D.; 🇺🇸 Artesia, California, United States

Centre For Health Care; 🇺🇸 Poway, California, United States

Bradley Kwapiszeski, MD; 🇺🇸 Shawnee Mission, Kansas, United States

Alan L Robin, M.D.; 🇺🇸 Baltimore, Maryland, United States

Great Lakes Eye Care; 🇺🇸 St Joseph, Michigan, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Lynbrook, New York, United States

United Medical Research Institute; 🇺🇸 Inglewood, California, United States

Aesthetic Eye Care Institute; 🇺🇸 Newport Beach, California, United States

Clayton Eye Center; 🇺🇸 Morrow, Georgia, United States

Bacharach practice; 🇺🇸 Petaluma, California, United States

Coastal Research Associates, LLC; 🇺🇸 Roswell, Georgia, United States

Taustine Eye Center; 🇺🇸 Louisville, Kentucky, United States

Jeffrey Schultz, M.D.; 🇺🇸 Bronx, New York, United States

Rochester Ophthalmological Group; 🇺🇸 Rochester, New York, United States

Charlotte Eye Ear Nose & Throat Associates, P.A.; 🇺🇸 Belmont, North Carolina, United States

Texan Eye; 🇺🇸 Austin, Texas, United States

The Eye Institute; 🇺🇸 Tulsa, Oklahoma, United States

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States

Medical Center Ophth. Associates; 🇺🇸 San Antonio, Texas, United States

Stacy R. Smith, M.D.; 🇺🇸 Salt Lake City, Utah, United States