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
  Purpose

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


Condition Intervention Phase
Glaucoma
Drug: latanoprost
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • additional IOP reduction obtained with cosopt in addition to xalatan

Estimated Enrollment: 56
Study Start Date: September 2007
Estimated Study Completion Date: July 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00906594

Locations
Brazil
University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00906594     History of Changes
Obsolete Identifiers: NCT00766922
Other Study ID Numbers: Merck-USP-01
Study First Received: May 18, 2009
Last Updated: May 20, 2009
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Latanoprost
Dorzolamide
Timolol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on October 02, 2014