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Efficacy and safety of a fixed combination of travoprost 0.004%/timolol 0.5% ophthalmic solution once daily for open-angle glaucoma or ocular hypertension.
Am J Ophthalmol. 2005 Aug; 140(2):242-50.AJ

Abstract

PURPOSE

To compare the efficacy of a fixed combination of travoprost 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plus travoprost 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular pressure (IOP) of subjects with open-angle glaucoma or ocular hypertension over 3 months.

DESIGN

Prospective, randomized, double-masked, parallel-group, active-controlled, multicenter trial.

METHODS

Patients comprised adult subjects (n = 403) of either gender with open-angle glaucoma or ocular hypertension in at least one eye. To qualify, the IOP had to be between 22 to 36 mm Hg in the same eye at two consecutive eligibility visits. The primary outcome variable was IOP measured with a Goldmann applanation tonometer.

RESULTS

Mean IOP ranged from 16.2 to 17.4 mm Hg with the combination travoprost/timolol compared with 15.4 to 16.8 mm Hg in the concomitant travoprost + timolol group, from baselines of 23.1 to 25.6 mm Hg and 22.9 to 25.0 mm Hg, respectively. The fixed combination of travoprost/timolol significantly lowered IOP by 7 to 9 mm, similar to the IOP reductions observed with concomitant therapy. The most frequent ocular adverse event was hyperemia that occurred in 14.3% and 23.4% of subjects treated with travoprost/timolol combination and concomitant travoprost + timolol, respectively.

CONCLUSIONS

Travoprost/timolol combination produces greater IOP reductions than the positive control, timolol 0.5%, and reductions that were similar to concomitant travoprost + timolol. This study demonstrates that the fixed combination of travoprost/timolol produces significant and clinically relevant reductions of IOP in a once-daily dosing regimen.

Authors+Show Affiliations

UPMC Eye Center, Eye and Ear Institute, Pittsburgh, Pennsylvania 15213, USA. schumanjs@upmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16086946

Citation

Schuman, Joel S., et al. "Efficacy and Safety of a Fixed Combination of Travoprost 0.004%/timolol 0.5% Ophthalmic Solution once Daily for Open-angle Glaucoma or Ocular Hypertension." American Journal of Ophthalmology, vol. 140, no. 2, 2005, pp. 242-50.
Schuman JS, Katz GJ, Lewis RA, et al. Efficacy and safety of a fixed combination of travoprost 0.004%/timolol 0.5% ophthalmic solution once daily for open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2005;140(2):242-50.
Schuman, J. S., Katz, G. J., Lewis, R. A., Henry, J. C., Mallick, S., Wells, D. T., Sullivan, E. K., Landry, T. A., Bergamini, M. V., & Robertson, S. M. (2005). Efficacy and safety of a fixed combination of travoprost 0.004%/timolol 0.5% ophthalmic solution once daily for open-angle glaucoma or ocular hypertension. American Journal of Ophthalmology, 140(2), 242-50.
Schuman JS, et al. Efficacy and Safety of a Fixed Combination of Travoprost 0.004%/timolol 0.5% Ophthalmic Solution once Daily for Open-angle Glaucoma or Ocular Hypertension. Am J Ophthalmol. 2005;140(2):242-50. PubMed PMID: 16086946.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a fixed combination of travoprost 0.004%/timolol 0.5% ophthalmic solution once daily for open-angle glaucoma or ocular hypertension. AU - Schuman,Joel S, AU - Katz,Gregory J, AU - Lewis,Richard A, AU - Henry,J Charles, AU - Mallick,Sushanta, AU - Wells,David T, AU - Sullivan,E Kenneth, AU - Landry,Theresa A, AU - Bergamini,Michael V W, AU - Robertson,Stella M, PY - 2004/07/27/received PY - 2005/02/25/revised PY - 2005/02/28/accepted PY - 2005/8/10/pubmed PY - 2005/9/1/medline PY - 2005/8/10/entrez SP - 242 EP - 50 JF - American journal of ophthalmology JO - Am. J. Ophthalmol. VL - 140 IS - 2 N2 - PURPOSE: To compare the efficacy of a fixed combination of travoprost 0.004%/timolol 0.5% every day in the morning with a concomitant regimen of timolol 0.5% every day in the morning, plus travoprost 0.004% every day in the evening; and timolol 0.5% twice daily on the intraocular pressure (IOP) of subjects with open-angle glaucoma or ocular hypertension over 3 months. DESIGN: Prospective, randomized, double-masked, parallel-group, active-controlled, multicenter trial. METHODS: Patients comprised adult subjects (n = 403) of either gender with open-angle glaucoma or ocular hypertension in at least one eye. To qualify, the IOP had to be between 22 to 36 mm Hg in the same eye at two consecutive eligibility visits. The primary outcome variable was IOP measured with a Goldmann applanation tonometer. RESULTS: Mean IOP ranged from 16.2 to 17.4 mm Hg with the combination travoprost/timolol compared with 15.4 to 16.8 mm Hg in the concomitant travoprost + timolol group, from baselines of 23.1 to 25.6 mm Hg and 22.9 to 25.0 mm Hg, respectively. The fixed combination of travoprost/timolol significantly lowered IOP by 7 to 9 mm, similar to the IOP reductions observed with concomitant therapy. The most frequent ocular adverse event was hyperemia that occurred in 14.3% and 23.4% of subjects treated with travoprost/timolol combination and concomitant travoprost + timolol, respectively. CONCLUSIONS: Travoprost/timolol combination produces greater IOP reductions than the positive control, timolol 0.5%, and reductions that were similar to concomitant travoprost + timolol. This study demonstrates that the fixed combination of travoprost/timolol produces significant and clinically relevant reductions of IOP in a once-daily dosing regimen. SN - 0002-9394 UR - https://www.unboundmedicine.com/medline/citation/16086946/Efficacy_and_safety_of_a_fixed_combination_of_travoprost_0_004/timolol_0_5_ophthalmic_solution_once_daily_for_open_angle_glaucoma_or_ocular_hypertension_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9394(05)00285-0 DB - PRIME DP - Unbound Medicine ER -