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A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00333125
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to compare the intraocular pressure (IOP)-lowering efficacy and safety of two combination products in patients with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav) Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt) Other: Timolol Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Timolol

Arm Intervention/treatment
Experimental: Travoprost/Timolol Drug: Travoprost 40 mcg/ml + Timolol 5 mg/ml eye drops, solution (DuoTrav)
One drop in the study eye(s) once daily, 9 PM, for 6 weeks
Other Name: DuoTrav

Other: Timolol Vehicle
One drop in the study eye(s) once daily for 6 weeks

Active Comparator: Dorzolamide/Timolol Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (Cosopt)
One drop in the study eye(s) twice daily for 6 weeks
Other Name: Cosopt




Primary Outcome Measures :
  1. Mean Intra-Ocular Pressure (IOP) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 or older.
  • Diagnosis of glaucoma or ocular hypertension.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Under 18.
  • Other protocol-defined exclusion criteria may apply.

Publications of Results:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00333125    
Other Study ID Numbers: C-05-25
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: May 2012
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Travoprost
Dorzolamide
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors