Text Size

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

This study has been terminated.
(Question raised by Ethics Committee)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00471068
First received: May 8, 2007
Last updated: April 7, 2012
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: Travatan
Drug: Cosopt
Drug: Placebo (Timolol Vehicle)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment [ Time Frame: At week 0 and week 6 ] [ Designated as safety issue: Yes ]
    IOP measured at week 6 minus IOP measured at baseline


Enrollment: 46
Study Start Date: March 2007
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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

Inclusion Criteria:

  • Patient with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • By Age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471068

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00471068     History of Changes
Other Study ID Numbers: EMD-05-03
Study First Received: May 8, 2007
Results First Received: October 21, 2009
Last Updated: April 7, 2012
Health Authority: Infarmed:Portugal

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Travoprost
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 22, 2013