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A 12-week, randomized, double-masked, multicenter study of the fixed combination of latanoprost and timolol in the evening versus the individual components.
Ophthalmology. 2006 Jan; 113(1):70-6.O

Abstract

PURPOSE

To compare the efficacy and tolerability of fixed-combination latanoprost and timolol applied in the evening with the concomitant use of the individual components.

DESIGN

Twelve-week, randomized, double-masked, multicenter study.

PARTICIPANTS

Five hundred seventeen randomized patients with ocular hypertension; open-angle, pigmentary, or exfoliation glaucoma; and baseline (after washout) intraocular pressure (IOP) levels between 23 and 33 mmHg.

METHODS

Patients received either the fixed combination of latanoprost and timolol once daily in the evening and a placebo in the morning and evening or the unfixed combination of latanoprost once daily in the evening and timolol in the morning and evening. Study visits were at weeks 2, 6, and 12.

MAIN OUTCOME MEASURES

The primary efficacy end point was mean change from baseline to week 12 in diurnal IOP (mean IOPs of 8 am, 12 pm, and 4 pm). The fixed combination was considered noninferior to the unfixed combination if the upper limit of the 95% confidence interval (CI) of the difference was <1.5 mmHg (analysis of covariance). Adverse events were recorded at each visit.

RESULTS

In all, 502 patients were included in intent-to-treat analyses (fixed combination, n = 255; unfixed combination, n = 247). For the fixed- and unfixed-combination groups, mean baseline diurnal IOP levels were 25.4 mmHg and 25.2 mmHg, respectively, and mean diurnal IOP reductions were 8.7 mmHg and 9.0 mmHg (between-treatment difference, 0.3 mmHg; 95% CI, -0.1 to 0.7 mmHg; P = 0.15). Both treatments were well tolerated.

CONCLUSIONS

The fixed combination of latanoprost and timolol administered once daily in the evening is not inferior to the unfixed combination of latanoprost once daily in the evening and timolol twice daily. The fixed combination provides an effective and well-tolerated alternative to multiple instillations.

Authors+Show Affiliations

Department of Ophthalmology, Univerisitäts-Augenklinik, University of Cologne, Cologne, Germany. michael.diestelhorst@medizin.uni-koeln.deNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16263174

Citation

Diestelhorst, Michael, et al. "A 12-week, Randomized, Double-masked, Multicenter Study of the Fixed Combination of Latanoprost and Timolol in the Evening Versus the Individual Components." Ophthalmology, vol. 113, no. 1, 2006, pp. 70-6.
Diestelhorst M, Larsson LI, European-Canadian Latanoprost Fixed Combination Study Group. A 12-week, randomized, double-masked, multicenter study of the fixed combination of latanoprost and timolol in the evening versus the individual components. Ophthalmology. 2006;113(1):70-6.
Diestelhorst, M., & Larsson, L. I. (2006). A 12-week, randomized, double-masked, multicenter study of the fixed combination of latanoprost and timolol in the evening versus the individual components. Ophthalmology, 113(1), 70-6.
Diestelhorst M, Larsson LI, European-Canadian Latanoprost Fixed Combination Study Group. A 12-week, Randomized, Double-masked, Multicenter Study of the Fixed Combination of Latanoprost and Timolol in the Evening Versus the Individual Components. Ophthalmology. 2006;113(1):70-6. PubMed PMID: 16263174.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 12-week, randomized, double-masked, multicenter study of the fixed combination of latanoprost and timolol in the evening versus the individual components. AU - Diestelhorst,Michael, AU - Larsson,Lill-Inger, AU - ,, Y1 - 2005/11/02/ PY - 2005/04/29/received PY - 2005/06/25/accepted PY - 2005/11/3/pubmed PY - 2006/1/13/medline PY - 2005/11/3/entrez SP - 70 EP - 6 JF - Ophthalmology JO - Ophthalmology VL - 113 IS - 1 N2 - PURPOSE: To compare the efficacy and tolerability of fixed-combination latanoprost and timolol applied in the evening with the concomitant use of the individual components. DESIGN: Twelve-week, randomized, double-masked, multicenter study. PARTICIPANTS: Five hundred seventeen randomized patients with ocular hypertension; open-angle, pigmentary, or exfoliation glaucoma; and baseline (after washout) intraocular pressure (IOP) levels between 23 and 33 mmHg. METHODS: Patients received either the fixed combination of latanoprost and timolol once daily in the evening and a placebo in the morning and evening or the unfixed combination of latanoprost once daily in the evening and timolol in the morning and evening. Study visits were at weeks 2, 6, and 12. MAIN OUTCOME MEASURES: The primary efficacy end point was mean change from baseline to week 12 in diurnal IOP (mean IOPs of 8 am, 12 pm, and 4 pm). The fixed combination was considered noninferior to the unfixed combination if the upper limit of the 95% confidence interval (CI) of the difference was <1.5 mmHg (analysis of covariance). Adverse events were recorded at each visit. RESULTS: In all, 502 patients were included in intent-to-treat analyses (fixed combination, n = 255; unfixed combination, n = 247). For the fixed- and unfixed-combination groups, mean baseline diurnal IOP levels were 25.4 mmHg and 25.2 mmHg, respectively, and mean diurnal IOP reductions were 8.7 mmHg and 9.0 mmHg (between-treatment difference, 0.3 mmHg; 95% CI, -0.1 to 0.7 mmHg; P = 0.15). Both treatments were well tolerated. CONCLUSIONS: The fixed combination of latanoprost and timolol administered once daily in the evening is not inferior to the unfixed combination of latanoprost once daily in the evening and timolol twice daily. The fixed combination provides an effective and well-tolerated alternative to multiple instillations. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/16263174/A_12_week_randomized_double_masked_multicenter_study_of_the_fixed_combination_of_latanoprost_and_timolol_in_the_evening_versus_the_individual_components_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(05)00901-2 DB - PRIME DP - Unbound Medicine ER -