A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of Two AR 12286/Travoprost Fixed-dose Combination Products Compared to Travatan® Z in Patients With Elevated Intraocular Pressure

Aerie Pharmaceuticals9 sites in 1 country93 target enrollmentDecember 2011

ConditionsGlaucoma Ocular Hypertension

Interventions0.25% AR-12286 / 0.004% travoprost 0.5% AR-12286, 0.004% travoprost 0.004% Travoprost

Overview

Phase: Phase 2
Intervention: 0.25% AR-12286 / 0.004% travoprost
Conditions: Glaucoma
Sponsor: Aerie Pharmaceuticals
Enrollment: 93
Locations: 9
Primary Endpoint: Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a double-masked, randomized, controlled study assessing the safety and ocular hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to Travatan® Z in patients with elevated intraocular pressure

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

April 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aerie Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years of age or greater.
•Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
•Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days apart. At second eligibility visit, IOP \>22 mmHg at 10:00, 12:00 and 16:00 hrs.
•Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
•Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria

•Ophthalmic (in either eye):
•Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
•Intraocular pressure \> 36 mm Hg
•Known hypersensitivity to travoprost, any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
•Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
•Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
•Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
•History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
•Contact lens wear within 30 minutes of instillation of study medication.
•Ocular medication of any kind within 30 days of Visit 1, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).