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

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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

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:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00333125     History of Changes
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:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Tetrahydrozoline
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Dorzolamide
Travoprost
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors