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A 6-week, multicenter, randomized, double-masked, parallel-group study comparing travoprost 0.004% to latanoprost 0.005% followed by 6-week, open-label treatment with travoprost 0.004%.
Clin Ther. 2007 Sep; 29(9):1915-23.CT

Abstract

OBJECTIVE

The aim of this study was to compare the tolerability and efficacy of once-daily travoprost 0.004% versus latanoprost 0.005% for 6 weeks followed by 6 weeks of once-daily travoprost 0.004% in decreasing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).

METHODS

This multicenter, randomized, doublemasked, active-controlled, parallel-group trial was conducted at 32 centers across Latin America. Patients aged > or =18 years with OAG or OH were randomly assigned to receive topical travoprost 0.004% or latanoprost 0.005% 1 drop QD (9 PM) for 6 weeks (masked phase). At 6 weeks, all patients were assigned to receive open-label travoprost 0.004% 1 drop QD (9 PM) for 6 additional weeks (open-label phase). Study visits were scheduled at weeks 1, 2, 4, 6, 8, and 12. At each study visit, IOP was measured at 5 PM (+/-1 hour; approximately 20 hours after study drug administration). IOP changes from baseline were combined (pooled) from the 1-, 2-, 4-, and 6-week data to provide a comparison between the 2 treatment groups. Ocular adverse events (AEs) were monitored using slit-lamp examination.

RESULTS

A total of 302 patients were enrolled (travoprost group, 155 patients; latanoprost group, 147 patients). The mean (SD) age of the travoprost group was 61.9 (10.6) years; 60.6% were female; and 47.1% were white. The mean (SD) age of the latanoprost group was 60.5 (12.4) years; 62.6% were female; and 49.0% were white. Mean IOP values were not significantly different between the travoprost and latanoprost groups at baseline (24.7 vs 24.2 mm Hg) or 6 weeks; however, the between-group difference in reductions from baseline in pooled IOP during the masked phase of the study was statistically significant (-8.3 vs -7.5 mm Hg; P = 0.009). At weeks 6 and 12, mean lOP levels were 16.1 and 16.2 mm Hg, respectively, in the travoprost group and 16.4 and 16.1 mm Hg in the group that was switched from latanoprost to travoprost (all, P = NS). The most common ocular AEs that occurred with masked travoprost, latanoprost, and open-label travoprost were hyperemia (26.9%, 12.2%, and 5.3%, respectively), discomfort (3.2%, 3.4%, and 1.1%), and pruritus (4.5%, 2.0%, and 2.1%).

CONCLUSIONS

In this population of patients with OAG or OH, 6-week treatment with travoprost 0.004% was associated with a significantly greater decrease from baseline in pooled IOP compared with latanoprost 0.005% 20 hours after administration. There were no significant differences between the 2 groups. Travoprost and latanoprost were well tolerated.

Authors+Show Affiliations

Pontificia Universidad Católica, Santiago, Chile.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18035191

Citation

Maul, Eugenio, et al. "A 6-week, Multicenter, Randomized, Double-masked, Parallel-group Study Comparing Travoprost 0.004% to Latanoprost 0.005% Followed By 6-week, Open-label Treatment With Travoprost 0.004%." Clinical Therapeutics, vol. 29, no. 9, 2007, pp. 1915-23.
Maul E, Carrasco FG, Costa VP, et al. A 6-week, multicenter, randomized, double-masked, parallel-group study comparing travoprost 0.004% to latanoprost 0.005% followed by 6-week, open-label treatment with travoprost 0.004%. Clin Ther. 2007;29(9):1915-23.
Maul, E., Carrasco, F. G., Costa, V. P., Casiraghi, J. F., Vargas, E., Sarmina, J. S., & Mayol, R. (2007). A 6-week, multicenter, randomized, double-masked, parallel-group study comparing travoprost 0.004% to latanoprost 0.005% followed by 6-week, open-label treatment with travoprost 0.004%. Clinical Therapeutics, 29(9), 1915-23.
Maul E, et al. A 6-week, Multicenter, Randomized, Double-masked, Parallel-group Study Comparing Travoprost 0.004% to Latanoprost 0.005% Followed By 6-week, Open-label Treatment With Travoprost 0.004%. Clin Ther. 2007;29(9):1915-23. PubMed PMID: 18035191.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 6-week, multicenter, randomized, double-masked, parallel-group study comparing travoprost 0.004% to latanoprost 0.005% followed by 6-week, open-label treatment with travoprost 0.004%. AU - Maul,Eugenio, AU - Carrasco,Félix Gil, AU - Costa,Vital Paulino, AU - Casiraghi,Javier F, AU - Vargas,Enrique, AU - Sarmina,Judith S, AU - Mayol,Renato, PY - 2007/06/18/accepted PY - 2007/11/24/pubmed PY - 2008/1/9/medline PY - 2007/11/24/entrez SP - 1915 EP - 23 JF - Clinical therapeutics JO - Clin Ther VL - 29 IS - 9 N2 - OBJECTIVE: The aim of this study was to compare the tolerability and efficacy of once-daily travoprost 0.004% versus latanoprost 0.005% for 6 weeks followed by 6 weeks of once-daily travoprost 0.004% in decreasing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). METHODS: This multicenter, randomized, doublemasked, active-controlled, parallel-group trial was conducted at 32 centers across Latin America. Patients aged > or =18 years with OAG or OH were randomly assigned to receive topical travoprost 0.004% or latanoprost 0.005% 1 drop QD (9 PM) for 6 weeks (masked phase). At 6 weeks, all patients were assigned to receive open-label travoprost 0.004% 1 drop QD (9 PM) for 6 additional weeks (open-label phase). Study visits were scheduled at weeks 1, 2, 4, 6, 8, and 12. At each study visit, IOP was measured at 5 PM (+/-1 hour; approximately 20 hours after study drug administration). IOP changes from baseline were combined (pooled) from the 1-, 2-, 4-, and 6-week data to provide a comparison between the 2 treatment groups. Ocular adverse events (AEs) were monitored using slit-lamp examination. RESULTS: A total of 302 patients were enrolled (travoprost group, 155 patients; latanoprost group, 147 patients). The mean (SD) age of the travoprost group was 61.9 (10.6) years; 60.6% were female; and 47.1% were white. The mean (SD) age of the latanoprost group was 60.5 (12.4) years; 62.6% were female; and 49.0% were white. Mean IOP values were not significantly different between the travoprost and latanoprost groups at baseline (24.7 vs 24.2 mm Hg) or 6 weeks; however, the between-group difference in reductions from baseline in pooled IOP during the masked phase of the study was statistically significant (-8.3 vs -7.5 mm Hg; P = 0.009). At weeks 6 and 12, mean lOP levels were 16.1 and 16.2 mm Hg, respectively, in the travoprost group and 16.4 and 16.1 mm Hg in the group that was switched from latanoprost to travoprost (all, P = NS). The most common ocular AEs that occurred with masked travoprost, latanoprost, and open-label travoprost were hyperemia (26.9%, 12.2%, and 5.3%, respectively), discomfort (3.2%, 3.4%, and 1.1%), and pruritus (4.5%, 2.0%, and 2.1%). CONCLUSIONS: In this population of patients with OAG or OH, 6-week treatment with travoprost 0.004% was associated with a significantly greater decrease from baseline in pooled IOP compared with latanoprost 0.005% 20 hours after administration. There were no significant differences between the 2 groups. Travoprost and latanoprost were well tolerated. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/18035191/A_6_week_multicenter_randomized_double_masked_parallel_group_study_comparing_travoprost_0_004_to_latanoprost_0_005_followed_by_6_week_open_label_treatment_with_travoprost_0_004_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(07)00287-1 DB - PRIME DP - Unbound Medicine ER -