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Dorzolamide/Timolol fixed combination versus concomitant administration of brimonidine and timolol in patients with elevated intraocular pressure: a 3-month comparison of efficacy, tolerability, and patient-reported measures.
J Glaucoma. 2004 Apr; 13(2):149-57.JG

Abstract

BACKGROUND

To compare the intraocular pressure (IOP) lowering effect, tolerability, and patient-reported measures of the dorzolamide/timolol fixed combination and the concomitant administration of brimonidine and timolol after 3 months.

METHODS

Four hundred ninety-two patients with ocular hypertension, primary open-angle glaucoma, exfoliative glaucoma, or pigmentary glaucoma participated in this randomized, observer-masked, multicenter study. Following 3 weeks of timolol monotherapy, patients with a peak IOP of > or = 2 mm Hg were randomized to receive either fixed combination dorzolamide/timolol twice daily or concomitant brimonidine plus timolol twice daily for 3 months. The IOP-lowering effects at peak and trough, tolerability, and patient-reported convenience and satisfaction were measured at months 1 and 3.

RESULTS

At month 3 peak, the dorzolamide/timolol group had an adjusted mean (SE) change from baseline IOP of -4.30 (0.24) mm Hg versus -5.27 (0.23) mm Hg in the brimonidine-plus-timolol group, with a treatment difference of 0.97 mm Hg (95% CI: 0.40, 1.53). At the month 3 trough timepoint and both month 1 timepoints, the 95% CIs of the treatment differences were within the prespecified comparability boundary of +/- 1.5 mm Hg. The incidence of drug-related adverse experiences was similar between treatment groups. Patient-reported assessments of convenience and satisfaction showed no statistically significant differences between treatment groups.

CONCLUSIONS

The IOP-lowering effect of the dorzolamide/timolol fixed combination and concomitant brimonidine plus timolol were comparable at 3 of the 4 timepoints measured. Patient-reported measures and the incidence of adverse experiences in both treatment groups were similar.

Authors+Show Affiliations

Southern California Glaucoma Consultants, Pasadena, California, USA.No 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

15097262

Citation

Solish, Alfred M., et al. "Dorzolamide/Timolol Fixed Combination Versus Concomitant Administration of Brimonidine and Timolol in Patients With Elevated Intraocular Pressure: a 3-month Comparison of Efficacy, Tolerability, and Patient-reported Measures." Journal of Glaucoma, vol. 13, no. 2, 2004, pp. 149-57.
Solish AM, DeLucca PT, Cassel DA, et al. Dorzolamide/Timolol fixed combination versus concomitant administration of brimonidine and timolol in patients with elevated intraocular pressure: a 3-month comparison of efficacy, tolerability, and patient-reported measures. J Glaucoma. 2004;13(2):149-57.
Solish, A. M., DeLucca, P. T., Cassel, D. A., Kolodny, A. H., Hustad, C. M., & Skobieranda, F. (2004). Dorzolamide/Timolol fixed combination versus concomitant administration of brimonidine and timolol in patients with elevated intraocular pressure: a 3-month comparison of efficacy, tolerability, and patient-reported measures. Journal of Glaucoma, 13(2), 149-57.
Solish AM, et al. Dorzolamide/Timolol Fixed Combination Versus Concomitant Administration of Brimonidine and Timolol in Patients With Elevated Intraocular Pressure: a 3-month Comparison of Efficacy, Tolerability, and Patient-reported Measures. J Glaucoma. 2004;13(2):149-57. PubMed PMID: 15097262.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dorzolamide/Timolol fixed combination versus concomitant administration of brimonidine and timolol in patients with elevated intraocular pressure: a 3-month comparison of efficacy, tolerability, and patient-reported measures. AU - Solish,Alfred M, AU - DeLucca,Paul T, AU - Cassel,Deborah A, AU - Kolodny,Andrea H, AU - Hustad,Carolyn M, AU - Skobieranda,Franck, PY - 2004/4/21/pubmed PY - 2004/5/18/medline PY - 2004/4/21/entrez SP - 149 EP - 57 JF - Journal of glaucoma JO - J Glaucoma VL - 13 IS - 2 N2 - BACKGROUND: To compare the intraocular pressure (IOP) lowering effect, tolerability, and patient-reported measures of the dorzolamide/timolol fixed combination and the concomitant administration of brimonidine and timolol after 3 months. METHODS: Four hundred ninety-two patients with ocular hypertension, primary open-angle glaucoma, exfoliative glaucoma, or pigmentary glaucoma participated in this randomized, observer-masked, multicenter study. Following 3 weeks of timolol monotherapy, patients with a peak IOP of > or = 2 mm Hg were randomized to receive either fixed combination dorzolamide/timolol twice daily or concomitant brimonidine plus timolol twice daily for 3 months. The IOP-lowering effects at peak and trough, tolerability, and patient-reported convenience and satisfaction were measured at months 1 and 3. RESULTS: At month 3 peak, the dorzolamide/timolol group had an adjusted mean (SE) change from baseline IOP of -4.30 (0.24) mm Hg versus -5.27 (0.23) mm Hg in the brimonidine-plus-timolol group, with a treatment difference of 0.97 mm Hg (95% CI: 0.40, 1.53). At the month 3 trough timepoint and both month 1 timepoints, the 95% CIs of the treatment differences were within the prespecified comparability boundary of +/- 1.5 mm Hg. The incidence of drug-related adverse experiences was similar between treatment groups. Patient-reported assessments of convenience and satisfaction showed no statistically significant differences between treatment groups. CONCLUSIONS: The IOP-lowering effect of the dorzolamide/timolol fixed combination and concomitant brimonidine plus timolol were comparable at 3 of the 4 timepoints measured. Patient-reported measures and the incidence of adverse experiences in both treatment groups were similar. SN - 1057-0829 UR - https://www.unboundmedicine.com/medline/citation/15097262/Dorzolamide/Timolol_fixed_combination_versus_concomitant_administration_of_brimonidine_and_timolol_in_patients_with_elevated_intraocular_pressure:_a_3_month_comparison_of_efficacy_tolerability_and_patient_reported_measures_ L2 - https://doi.org/10.1097/00061198-200404000-00012 DB - PRIME DP - Unbound Medicine ER -