June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
A 3 Month, Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol in Pediatric Glaucoma Patients
Author Affiliations & Notes
  • Robert M Feldman
    Ruiz Department of Ophthalmology and Visual Science, The University of Texas Medical School at Houston, Houston, TX
    Robert Cizik Eye Clinic, Houston, TX
  • Theresa Landry
    Alcon Research Ltd., Fort Worth, TX
  • El-Roy Dixon
    Dixon Eye Care, Albany, GA
  • Footnotes
    Commercial Relationships Robert Feldman, Alcon (C), Alcon (F); Theresa Landry, Alcon (E); El-Roy Dixon, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 5702. doi:
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      Robert M Feldman, Theresa Landry, El-Roy Dixon; A 3 Month, Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol in Pediatric Glaucoma Patients. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5702.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To demonstrate that the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004% preserved with POLYQUAD (PQ) is noninferior to timolol (0.5% or 0.25%) in pediatric patients with glaucoma or ocular hypertension.

Methods: Patients diagnosed with pediatric glaucoma (including secondary glaucomas and juvenile open-angle glaucoma) or ocular hypertension from 2 months to < 18 years of age were enrolled in the study. Eligible patients were randomized to receive either travoprost 0.004% PQ once daily in the evening (with travoprost vehicle instilled once daily in the morning to maintain masking) or timolol 0.5% (0.25% for patients < 3 years of age) twice daily (once in the morning and once in the evening) for 3 months. Efficacy and safety evaluations were done at Week 2, Week 6 and Month 3 following randomization.

Results: A total of 152 patients were randomized to study drug, including 77 patients in the travoprost 0.004% PQ group and 75 patients in the timolol group. The mean age (standard deviation [SD]) at baseline was 9.2 (4.8) years in the travoprost group and 10.0 (4.6) years in the timolol group. The mean (SD) IOP at baseline was 24.7 (4.6) mm Hg in the travoprost group and 24.2 (4.0) mm Hg in the timolol group. The least squares mean (standard error [SE]) reduction in IOP was 5.4 (0.98) mm Hg in the travoprost 0.004% PQ group and 5.3 (0.93) mm Hg in the timolol group for the primary efficacy endpoint using the intent-to-treat analysis set. The lease squares mean difference between treatment groups was -0.1 mm Hg, and the upper limit of the 95% confidence interval (-1.5, 1.4 mm Hg), was below the prespecified noninferiority margin of 3.0 mm Hg. No patient discontinued study participation due to an adverse event, and no serious adverse drug reaction was reported. The most common adverse events with the use of travoprost 0.004% were ocular hyperemia and growth of eyelashes reported at similar rates to what has been observed in the adult population.

Conclusions: This study demonstrated that the IOP-lowering efficacy of travoprost 0.004% PQ is noninferior to timolol in pediatric patients with glaucoma or ocular hypertension from 2 months to < 18 years of age with no increased risk for the use of travoprost 0.004% PQ identified. Travoprost provides efficacy in pediatric patients without the known systemic side effects associated with a beta-blocker.

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