Status:
COMPLETED
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
Lead Sponsor:
University of Sao Paulo
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed combination in patients undergoing monotherapy with latanoprost.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00906594
Start Date
September 1 2007
End Date
July 1 2008
Last Update
August 18 2015
Active Locations (1)
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1
University of Sao Paulo
São Paulo, São Paulo, Brazil