drugset / Trial / NCT00716859

A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

NCT00716859 ↗

Phase 3 Completed 139 enrolled Viatris Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

Timeline

Start
2008-07
Primary completion
2009-11
Completion
2009-11

Outcome

Missed primary endpoint

registry analysis (unspecified test); Timolol vs Latanoprost; Mean Difference (Net) 1.46 (95% CI -0.81 to 3.74) NCT00716859 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Latanoprost Small molecule 0.005 % —
Comparator Timolol Other / unclassified 0.5 % —

Indications