A 3-month safety and efficacy study of travoprost 0.004% ophthalmic solution compared with timolol in pediatric patients with glaucoma or ocular hypertension.

Abstract

PURPOSE:

To evaluate efficacy and safety of travoprost in pediatric patients with ocular hypertension or glaucoma and demonstrate its noninferiority to timolol.

METHODS:

Patients aged 2 months to <18 years with glaucoma or ocular hypertension were randomized to receive travoprost (0.004%) or timolol eye drops (0.25% for patients aged 2 months to <3 years and 0.5% for patients ≥3 years old) for 3 months in this double-masked, parallel-group study. Intraocular pressure (IOP) was measured and patients were evaluated at 2 weeks, 6 weeks, and 3 months after treatment. Change in IOP from baseline to 3 months was the primary endpoint, and the test of noninferiority was based on a margin of +3.0 mm Hg using the 95% 2-sided confidence interval of the mean change.

RESULTS:

Of 157 patients included (mean age, 9.6 years), 77 received travoprost and 75 timolol. All patients experienced a significant reduction in IOP in the study eye at 3 months: the mean IOP change from baseline was -5.4 mm Hg for travoprost; -5.3 mm Hg, for timolol. The mean difference between travoprost and timolol at month 3 was -0.1 mm Hg (95% CI, -1.5 to 1.4 mm Hg). The most common treatment-related adverse events for the travoprost group were ocular hyperemia and eyelash growth. No serious adverse events were reported.

CONCLUSIONS:

This study found travoprost to be noninferior to timolol in lowering IOP in patients with pediatric glaucoma or ocular hypertension. Travoprost was well-tolerated, and no treatment-related systemic adverse events were reported.

• Authors: El Roy Dixon, Theresa Landry, Subha Venkataraman, Nancy Gustafson, Craig Salem, Yasmin Bradfield, Leyla Ali Aljasim, Robert Feldman
• Journal: Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus (J AAPOS) Vol. 21 Issue 5 Pg. 370-374.e1 (Oct 2017) ISSN: 1528-3933 [Electronic] United States
• PMID: 28887006 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antihypertensive Agents
• Ophthalmic Solutions
• Timolol
• Travoprost

Topics

• Adolescent
• Antihypertensive Agents (adverse effects, therapeutic use)
• Child
• Child, Preschool
• Double-Blind Method
• Drug Therapy, Combination
• Equivalence Trials as Topic
• Female
• Glaucoma (drug therapy)
• Humans
• Infant
• Intraocular Pressure (drug effects)
• Male
• Ocular Hypertension (drug therapy)
• Ophthalmic Solutions
• Prospective Studies
• Timolol (adverse effects, therapeutic use)
• Tonometry, Ocular
• Travoprost (adverse effects, therapeutic use)