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A 6-week, double-masked, parallel-group study of the efficacy and safety of travoprost 0.004% compared with latanoprost 0:005%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension.

Abstract

OBJECTIVE

The objective of this study was to directly compare the intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004% eyedrops with the fixed combination of latanoprost 0.005%/timolol 0.5% eyedrops in patients with primary open-angle glaucoma or ocular hypertension.

METHODS

This was a randomized, double-masked, multicenter, parallel-group, active-controlled study. Adult subjects with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension were eligible to participate if their IOP was inadequately controlled with > or =4 weeks of beta-blocker monotherapy, as indicated by IOP of 22 to 36 mm Hg at 9 AM at screening. Patients were randomly assigned in a 1:1 ratio to receive placebo + travoprost or latanoprost/timolol + placebo. Patients in the travoprost group administered travoprost at 9 PM and placebo at 9 AM; patients in the latanoprost/timolol group administered latanoprost/timolol at 9 AM and placebo at 9 PM. IOP measurements were performed using Goldmann applanation tonometry at 9 AM and 5 PM at the week-2 and week-6 visits. Both volunteered and elicited reports of adverse events were collected; all patients who were randomized and received > or =1 dose of study drug were included in the safety analysis.

RESULTS

One hundred ten patients were randomized, of whom 106 patients were evaluable (travoprost, n = 50; latanoprost/timolol, n = 56). There were no statistically significant differences at baseline between the treatment groups, based on age group, sex, race, iris color, or diagnosis. Mean IOP values were not statistically different between groups at baseline or during treatment. In the pooled results for 9 Am assessment at weeks 2 and 6, mean (SEM) IOP reductions for travoprost and latanoprost/timolol were 7.0 (0.5) and 6.4 (0.5) mm Hg, respectively (P = NS). Adverse events related to therapy were mild in nature, and there were no statistically significant differences between the 2 treatment groups. The most frequently experienced adverse events in the travoprost group were ocular hyperemia (9.3%), foreign body sensation (5.6%), abnormal vision (1.9%), allergic reaction (1.9%), conjunctivitis (1.9%), dacryocystitis (1.9%), eye discharge (1.9%), eye pruritus (1.9%), lid edema (1.9%), lid erythema (1.9%), and tearing (1.9%). In the latanoprost/timolol group, the most frequently experienced adverse events were cataract (1.8%), dry eyes (1.8%), eye pruritus (1.8%), foreign body sensation (1.8%), and ocular hyperemia (1.8%).

CONCLUSIONS

Mean IOP changes from baseline for travoprost 0.004% and latanoprost 0.005%/timolol 0.5% fixed combination were not significantly different at follow-up in these patients. Both medications were well tolerated.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Glaucoma Research Unit, Moorfields Eye Hospital, London, United Kingdom. wendy.franks@moorfields.nhs.uk

    , ,

    Source

    Clinical therapeutics 28:3 2006 Mar pg 332-9

    MeSH

    Aged
    Antihypertensive Agents
    Cloprostenol
    Double-Blind Method
    Drug Combinations
    Female
    Glaucoma, Open-Angle
    Humans
    Intraocular Pressure
    Latanoprost
    Male
    Ocular Hypertension
    Ophthalmic Solutions
    Prostaglandins F, Synthetic
    Timolol
    Tonometry, Ocular
    Travoprost
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    16750448

    Citation

    Franks, Wendy A., et al. "A 6-week, Double-masked, Parallel-group Study of the Efficacy and Safety of Travoprost 0.004% Compared With Latanoprost 0:005%/timolol 0.5% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension." Clinical Therapeutics, vol. 28, no. 3, 2006, pp. 332-9.
    Franks WA, Renard JP, Cunliffe IA, et al. A 6-week, double-masked, parallel-group study of the efficacy and safety of travoprost 0.004% compared with latanoprost 0:005%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension. Clin Ther. 2006;28(3):332-9.
    Franks, W. A., Renard, J. P., Cunliffe, I. A., & Rojanapongpun, P. (2006). A 6-week, double-masked, parallel-group study of the efficacy and safety of travoprost 0.004% compared with latanoprost 0:005%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension. Clinical Therapeutics, 28(3), pp. 332-9.
    Franks WA, et al. A 6-week, Double-masked, Parallel-group Study of the Efficacy and Safety of Travoprost 0.004% Compared With Latanoprost 0:005%/timolol 0.5% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension. Clin Ther. 2006;28(3):332-9. PubMed PMID: 16750448.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A 6-week, double-masked, parallel-group study of the efficacy and safety of travoprost 0.004% compared with latanoprost 0:005%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension. AU - Franks,Wendy A, AU - Renard,Jean P, AU - Cunliffe,Ian A, AU - Rojanapongpun,Prin, PY - 2006/01/20/accepted PY - 2006/6/6/pubmed PY - 2006/7/11/medline PY - 2006/6/6/entrez SP - 332 EP - 9 JF - Clinical therapeutics JO - Clin Ther VL - 28 IS - 3 N2 - OBJECTIVE: The objective of this study was to directly compare the intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004% eyedrops with the fixed combination of latanoprost 0.005%/timolol 0.5% eyedrops in patients with primary open-angle glaucoma or ocular hypertension. METHODS: This was a randomized, double-masked, multicenter, parallel-group, active-controlled study. Adult subjects with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension were eligible to participate if their IOP was inadequately controlled with > or =4 weeks of beta-blocker monotherapy, as indicated by IOP of 22 to 36 mm Hg at 9 AM at screening. Patients were randomly assigned in a 1:1 ratio to receive placebo + travoprost or latanoprost/timolol + placebo. Patients in the travoprost group administered travoprost at 9 PM and placebo at 9 AM; patients in the latanoprost/timolol group administered latanoprost/timolol at 9 AM and placebo at 9 PM. IOP measurements were performed using Goldmann applanation tonometry at 9 AM and 5 PM at the week-2 and week-6 visits. Both volunteered and elicited reports of adverse events were collected; all patients who were randomized and received > or =1 dose of study drug were included in the safety analysis. RESULTS: One hundred ten patients were randomized, of whom 106 patients were evaluable (travoprost, n = 50; latanoprost/timolol, n = 56). There were no statistically significant differences at baseline between the treatment groups, based on age group, sex, race, iris color, or diagnosis. Mean IOP values were not statistically different between groups at baseline or during treatment. In the pooled results for 9 Am assessment at weeks 2 and 6, mean (SEM) IOP reductions for travoprost and latanoprost/timolol were 7.0 (0.5) and 6.4 (0.5) mm Hg, respectively (P = NS). Adverse events related to therapy were mild in nature, and there were no statistically significant differences between the 2 treatment groups. The most frequently experienced adverse events in the travoprost group were ocular hyperemia (9.3%), foreign body sensation (5.6%), abnormal vision (1.9%), allergic reaction (1.9%), conjunctivitis (1.9%), dacryocystitis (1.9%), eye discharge (1.9%), eye pruritus (1.9%), lid edema (1.9%), lid erythema (1.9%), and tearing (1.9%). In the latanoprost/timolol group, the most frequently experienced adverse events were cataract (1.8%), dry eyes (1.8%), eye pruritus (1.8%), foreign body sensation (1.8%), and ocular hyperemia (1.8%). CONCLUSIONS: Mean IOP changes from baseline for travoprost 0.004% and latanoprost 0.005%/timolol 0.5% fixed combination were not significantly different at follow-up in these patients. Both medications were well tolerated. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/16750448/A_6_week_double_masked_parallel_group_study_of_the_efficacy_and_safety_of_travoprost_0_004_compared_with_latanoprost_0:005/timolol_0_5_in_patients_with_primary_open_angle_glaucoma_or_ocular_hypertension_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(06)00066-X DB - PRIME DP - Unbound Medicine ER -