Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Phase 3 Completed 185 enrolled Allergan

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Timeline

Start: 2011-01
Primary completion: 2014-09
Completion: 2015-06

Outcome

Met primary endpoint

paper TFC superiority was demonstrated at all postbaseline visits (all, P < 0.001) through week 12 PMID 32089329 ↗

Publications

Belfort R Jr, Paula JS, Lopes Silva MJ, Della Paolera M, Kim T, Chen MY, Goodkin ML. Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆. Clin Ther. 2020 Feb;42(2):263-275. doi: 10.1016/j.clinthera.2019.12.008. Epub 2020 Feb 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bimatoprost	Other / unclassified	0.01 %	Other
Comparator	Brimonidine	Unknown	0.15 %	Other
Comparator	Brimonidine	Unknown	0.2 %	Other
Comparator	Timolol	Other / unclassified	0.5 %	Other