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

Abstract

AimTo 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.MethodsIn 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.Results561 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.ConclusionsBimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability.Trial registration numberNCT01177098.

Preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma and ocular hypertension: results of an open-label observational study

“…In another study comparing efficacy and safety of the preservative-free fixed combination of bimatoprost and timolol with the preserved formulation, Goldberg and co-workers found a similar IOP-lowering efficacy of both formulations of −9.16 to −7.98 mmHg for the bimatoprost/timolol preservative-free group, and from −9.03 to −7.72 for the preserved formulation. Between 86.3 and 90.6% of patients treated with the preservative-free bimatoprost/timolol fixed combination achieved at least a 20% IOP reduction at week 12 24. These results are comparable to the findings of the present study in the subgroup of treatment-naïve patients.…”

Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial

“…At each time point, examiners masked to the treatment assignment took 2 or 3 IOP measurements for each eye using a 2-person, masked reading method. 17 The primary efficacy outcome measure was time-matched IOP change from baseline.…”

Fixed-combination intraocular pressure-lowering therapy for glaucoma and ocular hypertension: advantages in clinical practice

“…Currently, several BAK-free preserved and preservative-free formulations of ocular hypotensive monotherapies and fixed-dose combinations (e.g., tafluprost, travoprost, bimatoprost, brimonidine, timolol, fixed-combination travoprost/timolol, fixed-combination dorzolamide/timolol) are commercially available. The tolerability and IOP-lowering efficacy of preservative-free fixed-combination tafluprost/ timolol and preservative-free fixed-combination bimatoprost/ timolol were recently demonstrated in two multicenter, Phase III clinical studies that included patients sensitive or allergic to preservatives (bimatoprost/timolol study) [88,89]. Both medications were noninferior to their comparators (preservative-free tafluprost/preservative-free timolol non-fixed concomitant therapy and BAK-preserved, fixed-combination bimatoprost/timolol, respectively).…”