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A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension.
J Glaucoma 2005; 14(5):392-9JG

Abstract

PURPOSE

The primary objective of this study was to compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination to the concomitant administration of travoprost 0.004% (TRAVATAN) and timolol 0.5% in subjects with open angle glaucoma or ocular hypertension.

METHODS

This was a randomized, multicenter, double-masked, active-controlled, parallel group study. Three hundred sixteen patients with open angle glaucoma or ocular hypertension were randomly assigned to travoprost 0.004%/timolol 0.5% ophthalmic solution fixed combination once daily in the morning or concomitant administration of timolol 0.5% once daily in the morning and travoprost 0.004% ophthalmic solution once daily in the evening. The efficacy and safety of the fixed combination were compared with concomitant therapy over three months. The primary efficacy outcome measure was mean intraocular pressure.

RESULTS

Both travoprost 0.004%/timolol 0.5% fixed combination and the concomitant administration of travoprost 0.004% and timolol 0.5% produced statistically significant reductions from baseline in IOP, with mean IOP ranging from 15.2 to 16.5 mm Hg in the patients using travoprost 0.004%/timolol 0.5% fixed combination compared with 14.7 to 16.1 mm Hg in the concomitant group. The upper 95.1% confidence limit for the differences in mean IOP (fixed combination minus concomitant) was < or =1.5 mm Hg at 7 of 9 visits, including all three 8 AM time points, 24-hours post-dose. Mean IOP reductions from baseline ranged from 7.4 to 9.4 mm Hg in the fixed combination group compared with 8.4 to 9.4 mm Hg with concomitant therapy. Safety analysis demonstrated equivalent safety between the two treatment groups.

CONCLUSIONS

A fixed combination of travoprost 0.004% and timolol 0.5% produced clinically relevant IOP reductions in patients with open angle glaucoma or ocular hypertension that were comparable to concomitant therapy with its components. Safety and tolerability of the fixed combination were also equivalent to concomitant therapy. Travoprost 0.004%/timolol 0.5% fixed combination offers IOP reduction equivalent to concomitant therapy, with potential benefits that include convenience (fewer bottles and drops per day), improved compliance, cost savings (based on fewer co-payments), and elimination of potential washout effects.

Authors+Show Affiliations

Kresge Eye Institute, Department of Opthalmology, Wayne State University School of Medicine, Detroit, MI 48201, USA. bhughes@med.wayne.eduNo 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

16148589

Citation

Hughes, Bret A., et al. "A Three-month, Multicenter, Double-masked Study of the Safety and Efficacy of Travoprost 0.004%/timolol 0.5% Ophthalmic Solution Compared to Travoprost 0.004% Ophthalmic Solution and Timolol 0.5% Dosed Concomitantly in Subjects With Open Angle Glaucoma or Ocular Hypertension." Journal of Glaucoma, vol. 14, no. 5, 2005, pp. 392-9.
Hughes BA, Bacharach J, Craven ER, et al. A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension. J Glaucoma. 2005;14(5):392-9.
Hughes, B. A., Bacharach, J., Craven, E. R., Kaback, M. B., Mallick, S., Landry, T. A., & Bergamini, M. V. (2005). A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension. Journal of Glaucoma, 14(5), pp. 392-9.
Hughes BA, et al. A Three-month, Multicenter, Double-masked Study of the Safety and Efficacy of Travoprost 0.004%/timolol 0.5% Ophthalmic Solution Compared to Travoprost 0.004% Ophthalmic Solution and Timolol 0.5% Dosed Concomitantly in Subjects With Open Angle Glaucoma or Ocular Hypertension. J Glaucoma. 2005;14(5):392-9. PubMed PMID: 16148589.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A three-month, multicenter, double-masked study of the safety and efficacy of travoprost 0.004%/timolol 0.5% ophthalmic solution compared to travoprost 0.004% ophthalmic solution and timolol 0.5% dosed concomitantly in subjects with open angle glaucoma or ocular hypertension. AU - Hughes,Bret A, AU - Bacharach,Jason, AU - Craven,E Randy, AU - Kaback,Martin B, AU - Mallick,Sushanta, AU - Landry,Theresa A, AU - Bergamini,Michael V W, PY - 2005/9/9/pubmed PY - 2005/11/16/medline PY - 2005/9/9/entrez SP - 392 EP - 9 JF - Journal of glaucoma JO - J. Glaucoma VL - 14 IS - 5 N2 - PURPOSE: The primary objective of this study was to compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination to the concomitant administration of travoprost 0.004% (TRAVATAN) and timolol 0.5% in subjects with open angle glaucoma or ocular hypertension. METHODS: This was a randomized, multicenter, double-masked, active-controlled, parallel group study. Three hundred sixteen patients with open angle glaucoma or ocular hypertension were randomly assigned to travoprost 0.004%/timolol 0.5% ophthalmic solution fixed combination once daily in the morning or concomitant administration of timolol 0.5% once daily in the morning and travoprost 0.004% ophthalmic solution once daily in the evening. The efficacy and safety of the fixed combination were compared with concomitant therapy over three months. The primary efficacy outcome measure was mean intraocular pressure. RESULTS: Both travoprost 0.004%/timolol 0.5% fixed combination and the concomitant administration of travoprost 0.004% and timolol 0.5% produced statistically significant reductions from baseline in IOP, with mean IOP ranging from 15.2 to 16.5 mm Hg in the patients using travoprost 0.004%/timolol 0.5% fixed combination compared with 14.7 to 16.1 mm Hg in the concomitant group. The upper 95.1% confidence limit for the differences in mean IOP (fixed combination minus concomitant) was < or =1.5 mm Hg at 7 of 9 visits, including all three 8 AM time points, 24-hours post-dose. Mean IOP reductions from baseline ranged from 7.4 to 9.4 mm Hg in the fixed combination group compared with 8.4 to 9.4 mm Hg with concomitant therapy. Safety analysis demonstrated equivalent safety between the two treatment groups. CONCLUSIONS: A fixed combination of travoprost 0.004% and timolol 0.5% produced clinically relevant IOP reductions in patients with open angle glaucoma or ocular hypertension that were comparable to concomitant therapy with its components. Safety and tolerability of the fixed combination were also equivalent to concomitant therapy. Travoprost 0.004%/timolol 0.5% fixed combination offers IOP reduction equivalent to concomitant therapy, with potential benefits that include convenience (fewer bottles and drops per day), improved compliance, cost savings (based on fewer co-payments), and elimination of potential washout effects. SN - 1057-0829 UR - https://www.unboundmedicine.com/medline/citation/16148589/A_three_month_multicenter_double_masked_study_of_the_safety_and_efficacy_of_travoprost_0_004/timolol_0_5_ophthalmic_solution_compared_to_travoprost_0_004_ophthalmic_solution_and_timolol_0_5_dosed_concomitantly_in_subjects_with_open_angle_glaucoma_or_ocular_hypertension_ L2 - http://Insights.ovid.com/pubmed?pmid=16148589 DB - PRIME DP - Unbound Medicine ER -