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Comparison of travoprost 0.0015% and 0.004% with timolol 0.5% in patients with elevated intraocular pressure: a 6-month, masked, multicenter trial.
Ophthalmology. 2002 May; 109(5):998-1008.O

Abstract

OBJECTIVE

To compare the safety and intraocular pressure (IOP)-lowering efficacy of once-daily travoprost (0.0015% and 0.004%) to twice-daily timolol 0.5%.

DESIGN

Prospective, 6-month, randomized, controlled, multicenter, double-masked, phase III study.

PARTICIPANTS

Six hundred five patients with open-angle glaucoma or ocular hypertension.

METHODS

Patients with an 8 AM IOP between 24 to 36 mmHg in at least one eye (the same eye) at two eligibility visits received either travoprost 0.0015%, travoprost 0.004% (dosed every day), or timolol 0.5% (dosed twice daily).

MAIN OUTCOME MEASURES

Mean IOP at 8 AM, 10 AM, and 4 PM in the patient's eye with the higher baseline IOP.

RESULTS

The mean IOP was significantly lower for both concentrations of travoprost compared with timolol. Travoprost was statistically superior to timolol at 9 of 13 visits, with differences in IOP reductions ranging from 0.9 to 1.8 mmHg (0.0015%) and 10 of 13 visits with differences in IOP reductions from 0.9 to 2.4 mmHg (0.004%). Mean IOP changes from baseline ranged from -6.0 to -7.5 mmHg (0.0015%), -6.5 to -8.0 mmHg (0.004%), and -5.2 to -7.0 mmHg for timolol. Hyperemia was experienced at rates of 29.2% (59 of 202) for travoprost 0.0015%, 42.8% (86 of 201) for travoprost 0.004%, and 8.9% (18 of 202) for timolol. Iris pigmentation changes were observed in 1.0% (2 of 200) of patients receiving travoprost 0.004% with no changes noted in the travoprost 0.0015% group or the timolol group. A decrease in pulse and systolic blood pressure was observed in the timolol group. There were no other clinically relevant or statistically significant changes from baseline in ocular signs or laboratory values, and no serious, related, unexpected adverse events were reported for any group.

CONCLUSIONS

Travoprost (0.0015% and 0.004%), dosed once daily in the evening, is statistically superior or equal to timolol 0.5% dosed twice daily at all treatment visits during this 6-month study. IOP reductions of up to 2.0 mmHg greater than timolol were found in the travoprost 0.004% pooled data group. Travoprost is safe and well tolerated in patients with open-angle glaucoma or ocular hypertension.

Authors+Show Affiliations

Glaucoma Associates of Texas, Dallas, Texas, USA.No 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
Clinical Trial, Phase III
Comparative Study
Evaluation Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11986110

Citation

Fellman, Ronald L., et al. "Comparison of Travoprost 0.0015% and 0.004% With Timolol 0.5% in Patients With Elevated Intraocular Pressure: a 6-month, Masked, Multicenter Trial." Ophthalmology, vol. 109, no. 5, 2002, pp. 998-1008.
Fellman RL, Sullivan EK, Ratliff M, et al. Comparison of travoprost 0.0015% and 0.004% with timolol 0.5% in patients with elevated intraocular pressure: a 6-month, masked, multicenter trial. Ophthalmology. 2002;109(5):998-1008.
Fellman, R. L., Sullivan, E. K., Ratliff, M., Silver, L. H., Whitson, J. T., Turner, F. D., Weiner, A. L., & Davis, A. A. (2002). Comparison of travoprost 0.0015% and 0.004% with timolol 0.5% in patients with elevated intraocular pressure: a 6-month, masked, multicenter trial. Ophthalmology, 109(5), 998-1008.
Fellman RL, et al. Comparison of Travoprost 0.0015% and 0.004% With Timolol 0.5% in Patients With Elevated Intraocular Pressure: a 6-month, Masked, Multicenter Trial. Ophthalmology. 2002;109(5):998-1008. PubMed PMID: 11986110.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of travoprost 0.0015% and 0.004% with timolol 0.5% in patients with elevated intraocular pressure: a 6-month, masked, multicenter trial. AU - Fellman,Ronald L, AU - Sullivan,E Kenneth, AU - Ratliff,Marla, AU - Silver,Lewis H, AU - Whitson,Jess T, AU - Turner,F Darell, AU - Weiner,Alan L, AU - Davis,Alberta A, AU - ,, PY - 2002/5/3/pubmed PY - 2002/5/17/medline PY - 2002/5/3/entrez SP - 998 EP - 1008 JF - Ophthalmology JO - Ophthalmology VL - 109 IS - 5 N2 - OBJECTIVE: To compare the safety and intraocular pressure (IOP)-lowering efficacy of once-daily travoprost (0.0015% and 0.004%) to twice-daily timolol 0.5%. DESIGN: Prospective, 6-month, randomized, controlled, multicenter, double-masked, phase III study. PARTICIPANTS: Six hundred five patients with open-angle glaucoma or ocular hypertension. METHODS: Patients with an 8 AM IOP between 24 to 36 mmHg in at least one eye (the same eye) at two eligibility visits received either travoprost 0.0015%, travoprost 0.004% (dosed every day), or timolol 0.5% (dosed twice daily). MAIN OUTCOME MEASURES: Mean IOP at 8 AM, 10 AM, and 4 PM in the patient's eye with the higher baseline IOP. RESULTS: The mean IOP was significantly lower for both concentrations of travoprost compared with timolol. Travoprost was statistically superior to timolol at 9 of 13 visits, with differences in IOP reductions ranging from 0.9 to 1.8 mmHg (0.0015%) and 10 of 13 visits with differences in IOP reductions from 0.9 to 2.4 mmHg (0.004%). Mean IOP changes from baseline ranged from -6.0 to -7.5 mmHg (0.0015%), -6.5 to -8.0 mmHg (0.004%), and -5.2 to -7.0 mmHg for timolol. Hyperemia was experienced at rates of 29.2% (59 of 202) for travoprost 0.0015%, 42.8% (86 of 201) for travoprost 0.004%, and 8.9% (18 of 202) for timolol. Iris pigmentation changes were observed in 1.0% (2 of 200) of patients receiving travoprost 0.004% with no changes noted in the travoprost 0.0015% group or the timolol group. A decrease in pulse and systolic blood pressure was observed in the timolol group. There were no other clinically relevant or statistically significant changes from baseline in ocular signs or laboratory values, and no serious, related, unexpected adverse events were reported for any group. CONCLUSIONS: Travoprost (0.0015% and 0.004%), dosed once daily in the evening, is statistically superior or equal to timolol 0.5% dosed twice daily at all treatment visits during this 6-month study. IOP reductions of up to 2.0 mmHg greater than timolol were found in the travoprost 0.004% pooled data group. Travoprost is safe and well tolerated in patients with open-angle glaucoma or ocular hypertension. SN - 0161-6420 UR - https://www.unboundmedicine.com/medline/citation/11986110/Comparison_of_travoprost_0_0015_and_0_004_with_timolol_0_5_in_patients_with_elevated_intraocular_pressure:_a_6_month_masked_multicenter_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(02)01010-2 DB - PRIME DP - Unbound Medicine ER -