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

Phase 3 Completed 192 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: 2011-03
Primary completion: 2013-09
Completion: 2013-09

Outcome

Met primary endpoint

paper TFC (n = 93) provided greater IOP reductions from baseline than DFC (n = 97) at week 12 (treatment difference, 0.85 mmHg; p = 0.028) PMID 29057117 ↗

Publications

Hartleben C, Parra JC, Batoosingh A, Bernstein P, Goodkin M. A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure. J Ophthalmol. 2017;2017:4586763. doi: 10.1155/2017/4586763. Epub 2017 Sep 19.

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