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

Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.


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.

Keywords: Clinical Trial; Drugs; Glaucoma; Treatment Medical.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Amides / adverse effects
  • Amides / pharmacokinetics
  • Amides / therapeutic use*
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / pharmacokinetics
  • Antihypertensive Agents / therapeutic use*
  • Cloprostenol / adverse effects
  • Cloprostenol / analogs & derivatives*
  • Cloprostenol / pharmacokinetics
  • Cloprostenol / therapeutic use
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Glaucoma, Open-Angle / drug therapy*
  • Humans
  • Intraocular Pressure / drug effects*
  • Male
  • Middle Aged
  • Ocular Hypertension / drug therapy*
  • Ophthalmic Solutions
  • Preservatives, Pharmaceutical / adverse effects
  • Preservatives, Pharmaceutical / therapeutic use*
  • Therapeutic Equivalency
  • Timolol / adverse effects
  • Timolol / pharmacokinetics
  • Timolol / therapeutic use*
  • Tonometry, Ocular
  • Treatment Outcome
  • Young Adult


  • Amides
  • Antihypertensive Agents
  • Drug Combinations
  • Ganfort
  • Ophthalmic Solutions
  • Preservatives, Pharmaceutical
  • Cloprostenol
  • Timolol

Associated data