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Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT00471068
Recruitment Status : Terminated (Question raised by Ethics Committee)
First Posted : May 9, 2007
Results First Posted : January 8, 2010
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: Travatan Drug: Cosopt Drug: Placebo (Timolol Vehicle) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Study Start Date : March 2007
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Travatan
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Drug: Travatan
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Drug: Placebo (Timolol Vehicle)
Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Active Comparator: Cosopt
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
Drug: Cosopt
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)



Primary Outcome Measures :
  1. Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment [ Time Frame: At week 0 and week 6 ]
    IOP measured at week 6 minus IOP measured at baseline



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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:

  • Patient with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • By Age

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): NCT00471068


Locations
Portugal
Coimbra
Coimbra, Portugal, 3000354
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Anna Grau Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00471068     History of Changes
Other Study ID Numbers: EMD-05-03
First Posted: May 9, 2007    Key Record Dates
Results First Posted: January 8, 2010
Last Update Posted: April 11, 2012
Last Verified: February 2010

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Tetrahydrozoline
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
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