Additive Intra-Ocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% on Monotherapy With Latanoprost in Patients With Elevated Intra-Ocular Pressure

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00906594
First received: May 18, 2009
Last updated: May 20, 2009
Last verified: May 2009

May 18, 2009
May 20, 2009
September 2007
January 2008   (final data collection date for primary outcome measure)
additional IOP reduction obtained with cosopt in addition to xalatan
Same as current
Complete list of historical versions of study NCT00906594 on ClinicalTrials.gov Archive Site
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Additive Intra-Ocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% on Monotherapy With Latanoprost in Patients With Elevated Intra-Ocular Pressure
Additive Intra-Ocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% on Monotherapy With Latanoprost in Patients With Elevated Intra-Ocular Pressure: a Prospective, Four-Week, Open-Label, Randomized, Controlled Clinical Trial.

The purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed combination in patients undergoing monotherapy with latanoprost.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Drug: latanoprost
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
July 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

All patients were at least 18 years old, with unilateral or bilateral open-angle glaucoma (defined as IOP > 21 mmHg, mean of three consecutive measurements, at any time during the day, at the moment of glaucoma diagnosis) or ocular hypertension (IOP> 25 mmHg, mean of three consecutive measurements, at anytime during the day, at the moment of diagnosis). Glaucoma was defined as a reproducible glaucomatous visual field defect based on GHT outside normal limits and/or PSD lower than 0,5% or glaucomatous changes of the optic disc associated to elevated IOP. A visual acuity (ETDRS) of 20/80 or better was required for randomization.

Exclusion Criteria:

Included woman of childbearing potential, pregnancy, systemic contra-indication to beta-blocker therapy, argon laser trabeculoplasty three months before screening visit, any history of filtering surgery, ocular surgery or uveitis three months before screening visit, hypersensitivity to any compound of the study drugs, concomitant use of any experimental drug, any condition in which treatment with beta-blocker is contraindicated or any other abnormal and/or ocular condition or symptom that would prevent study participation, according to the judgment of the investigator. The use of systemic beta-blocker, if needed, was allowed and not considered an exclusion criterion. Latanoprost non-responders defined as lower than 15% IOP reduction after run-in period with latanoprost monotherapy were excluded from the study.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00906594
Merck-USP-01
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University of Sao Paulo
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University of Sao Paulo
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP