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

J AAPOS. 2017 Oct;21(5):370-374.e1. doi: 10.1016/j.jaapos.2017.07.202. Epub 2017 Sep 6.


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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / 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
  • Timolol / therapeutic use*
  • Tonometry, Ocular
  • Travoprost / adverse effects
  • Travoprost / therapeutic use*


  • Antihypertensive Agents
  • Ophthalmic Solutions
  • Timolol
  • Travoprost