A double-masked, randomized, parallel comparison of a fixed combination of bimatoprost 0.03%/timolol 0.5% with non-fixed combination use in patients with glaucoma or ocular hypertension

Eur J Ophthalmol. Jan-Feb 2007;17(1):53-62.

Abstract

Purpose: To compare the safety and efficacy of the fixed combination product with non-fixed combination use of the same active ingredients in separate bottles (bimatoprost once-daily [qd], and timolol twice-daily [bid]). A bimatoprost 0.03% qd treatment arm was used for validation of the study.

Method: This was a double-masked, randomized, parallel study in 445 patients with open-angle glaucoma or ocular hypertension. They were randomized in a ratio of 2:2:1 to receive bilateral treatment with the fixed combination, non-fixed combination treatment, or bimatoprost alone.

Results: Comparing the fixed combination and non-fixed combination, the non-inferiority margin of 1.5 mm Hg was met at all three timepoints for mean intraocular pressure (IOP), and a margin of 1.0 mm Hg for mean diurnal IOP. The incidence of conjunctival hyperemia was statistically significantly lower (p=0.014) in the fixed combination group (8.5%, 15/176) compared with the bimatoprost group (18.9%, 17/90) and the non-fixed combination group (12.5%, 22/176).

Conclusions: The fixed combination of bimatoprost 0.03%/timolol 0.5% administered once daily was comparable in ocular hypotensive efficacy to the non-fixed combination. The lower propensity of the fixed combination to elicit conjunctival hyperemia suggests a superior comparative benefit/risk assessment of the fixed combination in the treatment of elevated IOP.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amides / administration & dosage
  • Amides / adverse effects
  • Amides / therapeutic use*
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / therapeutic use*
  • Bimatoprost
  • Cloprostenol / administration & dosage
  • Cloprostenol / adverse effects
  • Cloprostenol / analogs & derivatives*
  • Cloprostenol / therapeutic use
  • Double-Blind Method
  • Drug Combinations
  • Drug Therapy, Combination
  • Female
  • Glaucoma, Open-Angle / drug therapy*
  • Humans
  • Intraocular Pressure / drug effects
  • Lipids / administration & dosage
  • Lipids / adverse effects
  • Lipids / therapeutic use*
  • Male
  • Middle Aged
  • Ocular Hypertension / drug therapy
  • Ophthalmic Solutions / administration & dosage
  • Ophthalmic Solutions / adverse effects
  • Ophthalmic Solutions / therapeutic use
  • Timolol / administration & dosage
  • Timolol / adverse effects
  • Timolol / therapeutic use*
  • Tonometry, Ocular
  • Treatment Outcome

Substances

  • Amides
  • Antihypertensive Agents
  • Drug Combinations
  • Lipids
  • Ophthalmic Solutions
  • Cloprostenol
  • Timolol
  • Bimatoprost