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

NCT ID: NCT00906594

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-07-31

Brief Summary

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

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Latanoprost

Latanoprost mono therapy

Group Type: ACTIVE_COMPARATOR

latanoprost

Intervention Type: DRUG

Latanoprost + Fixed combination

Latnoprost + Fixed combination

Group Type: EXPERIMENTAL

latanoprost

Intervention Type: DRUG

Interventions

latanoprost

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Hatanaka

Head, Glaucoma Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Merck-USP-01

Identifier Type: -

Identifier Source: org_study_id

NCT00766922

Identifier Type: -

Identifier Source: nct_alias