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Efficacy and tolerability of the dorzolamide 2%/timolol 0.5% combination (COSOPT) versus 0.005% (XALATAN) in the treatment of ocular hypertension or glaucoma: results from two randomized clinical trials.
Acta Ophthalmol Scand. 2004 Feb; 82(1):42-8.AO

Abstract

PURPOSE

To compare the efficacy of the fixed dorzolamide 2%/timolol 0.5% combination (COSOPT) versus latanoprost 0.005% (XALATAN).

METHODS

Two 3-month, parallel group, randomized, observer-masked and patient-masked, multicentre, clinical trials were performed in patients with ocular hypertension or open-angle glaucoma. Study 1 (n=256) was conducted in the United States and Study 2 (n=288) was conducted in Europe/Israel. Patients could be included whether or not they were currently taking ocular hypotensive therapy, and regardless of the effectiveness of any previous therapy. Patients were washed out from their usual ocular hypotensive medications and then those with a baseline intraocular pressure (IOP) >/= 24 mmHg were randomized to either the dorzolamide/timolol combination eye drops twice daily or latanoprost eye drops once daily in both eyes. Efficacy was assessed by daytime diurnal IOP (the mean of measurements made at 0800, 1000, 1400 and 1600 h).

RESULTS

At baseline, the mean daytime diurnal IOP was 26.1 mmHg in the dorzolamide/timolol combination group versus 25.6 mmHg in the latanoprost group in Study 1, and 25.3 mmHg in the dorzolamide/timolol combination group versus 24.7 mmHg in the latanoprost group in Study 2. After 3 months, the mean daytime diurnal IOP was 18.9 mmHg for the dorzolamide/timolol combination versus 18.4 mmHg for latanoprost in Study 1, and 17.4 mmHg for the dorzolamide/timolol combination versus 17.5 for latanoprost in Study 2. The difference between treatments in mean IOP change at 3 months was -0.04 mmHg [95% confidence interval (CI) -0.85, 0.77] in Study 1, and -0.57 mmHg (95% CI -1.31, 0.16) in Study 2. The probability that the true difference lay between -1.5 and 1.5 mmHg, the predefined bounds for equivalence, was >0.950 in both studies. Both treatments were well tolerated over 3 months, although ocular stinging occurred more frequently with the dorzolamide/timolol combination.

CONCLUSIONS

The dorzolamide/timolol combination and latanoprost were equally effective at lowering IOP.

Authors+Show Affiliations

Glaucoma Division, New Jersey Medical School, UMDNJ, Newark, NJ 07101-1709, USA. Fechtner@UMDNJ.eduNo 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

14982045

Citation

Fechtner, Robert D., et al. "Efficacy and Tolerability of the Dorzolamide 2%/timolol 0.5% Combination (COSOPT) Versus 0.005% (XALATAN) in the Treatment of Ocular Hypertension or Glaucoma: Results From Two Randomized Clinical Trials." Acta Ophthalmologica Scandinavica, vol. 82, no. 1, 2004, pp. 42-8.
Fechtner RD, Airaksinen PJ, Getson AJ, et al. Efficacy and tolerability of the dorzolamide 2%/timolol 0.5% combination (COSOPT) versus 0.005% (XALATAN) in the treatment of ocular hypertension or glaucoma: results from two randomized clinical trials. Acta Ophthalmol Scand. 2004;82(1):42-8.
Fechtner, R. D., Airaksinen, P. J., Getson, A. J., Lines, C. R., & Adamsons, I. A. (2004). Efficacy and tolerability of the dorzolamide 2%/timolol 0.5% combination (COSOPT) versus 0.005% (XALATAN) in the treatment of ocular hypertension or glaucoma: results from two randomized clinical trials. Acta Ophthalmologica Scandinavica, 82(1), 42-8.
Fechtner RD, et al. Efficacy and Tolerability of the Dorzolamide 2%/timolol 0.5% Combination (COSOPT) Versus 0.005% (XALATAN) in the Treatment of Ocular Hypertension or Glaucoma: Results From Two Randomized Clinical Trials. Acta Ophthalmol Scand. 2004;82(1):42-8. PubMed PMID: 14982045.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of the dorzolamide 2%/timolol 0.5% combination (COSOPT) versus 0.005% (XALATAN) in the treatment of ocular hypertension or glaucoma: results from two randomized clinical trials. AU - Fechtner,Robert D, AU - Airaksinen,P Juhani, AU - Getson,Albert J, AU - Lines,Christopher R, AU - Adamsons,Ingrid A, AU - ,, PY - 2004/2/26/pubmed PY - 2004/3/19/medline PY - 2004/2/26/entrez SP - 42 EP - 8 JF - Acta ophthalmologica Scandinavica JO - Acta Ophthalmol Scand VL - 82 IS - 1 N2 - PURPOSE: To compare the efficacy of the fixed dorzolamide 2%/timolol 0.5% combination (COSOPT) versus latanoprost 0.005% (XALATAN). METHODS: Two 3-month, parallel group, randomized, observer-masked and patient-masked, multicentre, clinical trials were performed in patients with ocular hypertension or open-angle glaucoma. Study 1 (n=256) was conducted in the United States and Study 2 (n=288) was conducted in Europe/Israel. Patients could be included whether or not they were currently taking ocular hypotensive therapy, and regardless of the effectiveness of any previous therapy. Patients were washed out from their usual ocular hypotensive medications and then those with a baseline intraocular pressure (IOP) >/= 24 mmHg were randomized to either the dorzolamide/timolol combination eye drops twice daily or latanoprost eye drops once daily in both eyes. Efficacy was assessed by daytime diurnal IOP (the mean of measurements made at 0800, 1000, 1400 and 1600 h). RESULTS: At baseline, the mean daytime diurnal IOP was 26.1 mmHg in the dorzolamide/timolol combination group versus 25.6 mmHg in the latanoprost group in Study 1, and 25.3 mmHg in the dorzolamide/timolol combination group versus 24.7 mmHg in the latanoprost group in Study 2. After 3 months, the mean daytime diurnal IOP was 18.9 mmHg for the dorzolamide/timolol combination versus 18.4 mmHg for latanoprost in Study 1, and 17.4 mmHg for the dorzolamide/timolol combination versus 17.5 for latanoprost in Study 2. The difference between treatments in mean IOP change at 3 months was -0.04 mmHg [95% confidence interval (CI) -0.85, 0.77] in Study 1, and -0.57 mmHg (95% CI -1.31, 0.16) in Study 2. The probability that the true difference lay between -1.5 and 1.5 mmHg, the predefined bounds for equivalence, was >0.950 in both studies. Both treatments were well tolerated over 3 months, although ocular stinging occurred more frequently with the dorzolamide/timolol combination. CONCLUSIONS: The dorzolamide/timolol combination and latanoprost were equally effective at lowering IOP. SN - 1395-3907 UR - https://www.unboundmedicine.com/medline/citation/14982045/Efficacy_and_tolerability_of_the_dorzolamide_2/timolol_0_5_combination__COSOPT__versus_0_005__XALATAN__in_the_treatment_of_ocular_hypertension_or_glaucoma:_results_from_two_randomized_clinical_trials_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=1395-3907&date=2004&volume=82&issue=1&spage=42 DB - PRIME DP - Unbound Medicine ER -