Polyquaternium-1-Preserved Travoprost 0.003% or Benzalkonium Chloride-Preserved Travoprost 0.004% for Glaucoma and Ocular Hypertension.

Abstract

PURPOSE:

To demonstrate equivalence of polyquaternium-1-preserved travoprost 0.003% with benzalkonium chloride-preserved travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension.

DESIGN:

Double-masked, randomized, 2-treatment, equivalence clinical trial.

METHODS:

setting: Multicenter clinical trial conducted in 60 centers in the United States and Europe.

PATIENT POPULATION:

Adult patients with open-angle glaucoma or ocular hypertension. One eye per patient was analyzed.

INTERVENTION:

Patients were randomized 1:1 to receive polyquaternium-1-preserved travoprost 0.003% (n = 442) or benzalkonium chloride-preserved travoprost 0.004% (n = 422) once daily for 3 months.

MAIN OUTCOME MEASURES:

Mean intraocular pressure (IOP) was assessed at 8 AM, 10 AM, and 4 PM at week 2, week 6, and month 3. Supportive outcomes were mean and percent IOP change, percentage of patients achieving IOP <18 mm Hg or ≥30% IOP reduction, and adverse events.

RESULTS:

Mean IOP was similar between groups at all study visits (travoprost 0.003% range, 17.5-18.9 mm Hg; travoprost 0.004% range, 17.4-19.0 mm Hg). Mean change (least squares mean differences, -0.1 to 0.3 mm Hg; 95% confidence interval, -0.5 to 0.7 mm Hg) and percentage change (travoprost 0.003%, 28.4%-30.7%; travoprost 0.004%, 28.5%-31.0%) from baseline were comparable. The percentages of patients with IOP <18 mm Hg and ≥30% reduction of IOP were also similar. Hyperemia was the most frequent treatment-related adverse event with both formulations (travoprost 0.003%, 11.8%; travoprost 0.004%, 14.5%).

CONCLUSIONS:

In patients with open-angle glaucoma or ocular hypertension, polyquaternium-1-preserved travoprost 0.003% solution provided equivalent IOP-lowering efficacy to that of benzalkonium chloride-preserved travoprost 0.004%.

• Authors: James H Peace, Peter Ahlberg, Mathias Wagner, John M Lim, David Wirta, James D Branch
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 160 Issue 2 Pg. 266-274.e1 (Aug 2015) ISSN: 1879-1891 [Electronic] United States
• PMID: 25935098 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antihypertensive Agents
• Benzalkonium Compounds
• Ophthalmic Solutions
• Polymers
• Preservatives, Pharmaceutical
• Cloprostenol
• polyquaternium 1
• Travoprost

Topics

• Aged
• Antihypertensive Agents (administration & dosage)
• Benzalkonium Compounds (administration & dosage)
• Cloprostenol (administration & dosage, analogs & derivatives)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Glaucoma, Open-Angle (drug therapy, physiopathology)
• Humans
• Intraocular Pressure
• Male
• Ocular Hypertension (drug therapy, physiopathology)
• Ophthalmic Solutions (administration & dosage)
• Polymers (administration & dosage)
• Preservatives, Pharmaceutical (administration & dosage)
• Retrospective Studies
• Tonometry, Ocular
• Travoprost
• Treatment Outcome