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Clinical Trials |

Fixed Combination of Latanoprost and Timolol vs Individual Components for Primary Open-Angle Glaucoma or Ocular Hypertension A Randomized, Double-Masked Study

Eve J. Higginbotham, MD; Kenneth W. Olander, MD; Elizabeth E. Kim, MD; John W. Grunden, PharmD; Kenneth K. Kwok, MS; Charles S. Tressler, MD ; United States Fixed-Combination Study Group
Arch Ophthalmol. 2010;128(2):165-172. doi:10.1001/archophthalmol.2009.384.
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Objective  To assess the efficacy and safety of fixed-combination latanoprost-timolol (FCLT) vs latanoprost or timolol monotherapy.

Methods  This 12-week, randomized, double-masked, parallel-group study included patients with open-angle glaucoma or ocular hypertension treated with a β-blocker and with baseline intraocular pressure (IOP) of 26 through 36 mm Hg. Following washout, eligible patients were randomized to once-daily FCLT in the evening, latanoprost in the evening, or timolol in the morning.

Main Outcome Measures  Postbaseline IOP assessments at 8 AM, 10 AM, and 4 PM at weeks 2, 6, and 12; statistical superiority of FCLT for the 18 pairwise comparisons between FCLT and the 2 monotherapies, using analysis of variance.

Results  All therapies resulted in significant IOP reductions from baseline. Pairwise comparisons favored FCLT at all time points. When the 18 comparisons were tested simultaneously, FCLT was statistically superior to latanoprost at 7 of 9 time points and at all 9 time points when compared with timolol. In addition, FCLT was associated with greater percentage reductions in diurnal IOP levels and a greater likelihood of achieving lower mean diurnal IOP levels. Diurnal IOP reductions of 30% or more from baseline to week 12 were achieved by 73.5%, 57.5%, and 32.8% of those treated with FCLT, latanoprost, and timolol, respectively (P = .007 for FCLT vs timolol; P < .001 for FCLT vs latanoprost). All therapies were well tolerated.

Conclusions  Fixed-combination latanoprost-timolol therapy is as safe and effective in lowering IOP in patients with either ocular hypertension or glaucoma as monotherapy with latanoprost or timolol. Combination therapy can be used to treat patients for whom monotherapy does not provide sufficient IOP reduction.

Application to Clinical Practice  The simplicity, efficacy, and tolerability of FCLT contribute to its utility in clinical practice.

Trial Registration  clinicaltrials.gov Identifier NCT00277498

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Figure 1.

Participant disposition. Asterisk indicates of 421 randomized participants, 27 (6.4%) were excluded owing to the loss of source data and to protocol deviations; dagger, the number of participants in the intent-to-treat and safety populations.

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Figure 2.

Participants reaching prespecified percentages of mean diurnal intraocular pressure (IOP) reduction at week 12 (intent-to-treat population; last observation carried forward). *P < .01 for the difference between the combination therapy and monotherapy groups.

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Figure 3.

Participants reaching prespecified mean diurnal intraocular pressure (IOP) at week 12 (intent-to-treat population; last observation carried forward). *P < .01 for the difference between the combination therapy and monotherapy groups; †P < .03 for the difference between the combination therapy and monotherapy groups.

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