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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

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ClinicalTrials.gov Identifier: NCT00906594
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Marcelo Hatanaka, University of Sao Paulo

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

Condition or disease Intervention/treatment Phase
Glaucoma Drug: latanoprost Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Latanoprost
Latanoprost mono therapy
Drug: latanoprost
Experimental: Latanoprost + Fixed combination
Latnoprost + Fixed combination
Drug: latanoprost



Primary Outcome Measures :
  1. additional IOP reduction obtained with cosopt in addition to xalatan [ Time Frame: 4 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906594


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

Responsible Party: Marcelo Hatanaka, Head, Glaucoma Service, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00906594     History of Changes
Obsolete Identifiers: NCT00766922
Other Study ID Numbers: Merck-USP-01
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015

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