Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial.

Author(s): Goldberg I(1), Gil Pina R(2), Lanzagorta-Aresti A(3), Schiffman RM(4), Liu C(4), Bejanian M(4).

Affiliation(s): Author information: (1)Department of Ophthalmology, University of Sydney, Sydney Eye Hospital, Sydney, Australia. (2)Clinica Oftalmologica Rafael Gil Pina, Huelva, Spain. (3)Fundacion Oftalmologica Del Mediterraneo, Valencia, Spain. (4)Allergan, Inc., Irvine, California, USA (at the time the study was conducted).

Publication date & source: 2014, Br J Ophthalmol. , 98(7):926-31

AIM: To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. METHODS: In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. RESULTS: 561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p<0.001). Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol. Ocular adverse events were similar between treatment groups, with conjunctival hyperaemia being the most frequent. Most were mild or moderate in severity. CONCLUSIONS: Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. TRIAL REGISTRATION NUMBER: NCT01177098.