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Fixed combination of latanoprost and timolol vs individual components for primary open-angle glaucoma or ocular hypertension: a randomized, double-masked study.

Author(s): Higginbotham EJ, Olander KW, Kim EE, Grunden JW, Kwok KK, Tressler CS; United States Fixed-Combination Study Group.

Collaborators: Abrams MA, Affleck A, Al-Aswad LA, Alpern LM, Archer KF, Berdy GJ, Coeur C, Bernstein MR, Bluestein EC, Branch JD, Cameron BD, Carim MM, Coronado T, Davitt WF, Digby DJ, Evans RM, Flowers BE, Godfrey DG, Hasty BR, Herndon L, Iwach AG, Juzych MS, Kanengiser BE, Korenfeld MS, Krupin T, Latina MA, Lazarus HS, Lederer CM Jr, Lee DA, Lee RK, Levy NS, Lewis RA, Lipka AC, Macey JI, McGarey DL, McMahon CD, Mansouri A, Markoff JI, Moroi SE, Olander KW, Parrow KA, Piltz-Seymour JR, Rich CC, Rubin JM, Sall KN, Schenker HI, Shrader CE, Sonty S, Spitzer JA, Stamler JF, Stewart RH Jr, Tharp AW, Thatcher DB, Tibbetts JH, Tubbs CB, Walters TR, Weston JM, Williams RD, Wirta D.

Affiliation(s): Morehouse School of Medicine and Emory University School of Medicine, Atlanta, Georgia, USA. fcwejh6786@aol.com

Publication date & source: 2010, Arch Ophthalmol. , 128(2):165-72

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 beta-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.

Page last updated: 2013-02-10

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