A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma

Phase 3 Completed 528 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Timeline

Start: 2005-12
Primary completion: —
Completion: 2007-06

Outcome

Mixed primary results

paper MAIN OUTCOME MEASURES: Postbaseline IOP assessments at 8 am, 10 am, and 4 pm at weeks 2, 6, and 12; statistical superiority of FCLT for the 18 pairwise comparisons PMID 20142538 ↗

paper FCLT was statistically superior to latanoprost at 7 of 9 time points and at all 9 time points when compared with timolol. PMID 20142538 ↗

Publications

Higginbotham EJ, Olander KW, Kim EE, Grunden JW, Kwok KK, Tressler CS; United States Fixed-Combination Study Group. Fixed combination of latanoprost and timolol vs individual components for primary open-angle glaucoma or ocular hypertension: a randomized, double-masked study. Arch Ophthalmol. 2010 Feb;128(2):165-72. doi: 10.1001/archophthalmol.2009.384.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Latanoprost	Small molecule	—	—
Subject	Timolol	Other / unclassified	—	—