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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

May 8, 2007
April 7, 2012
March 2007
August 2008   (final data collection date for primary outcome measure)
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
IOP [ Time Frame: Duration ]
Complete list of historical versions of study NCT00471068 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Open-angle Glaucoma
  • Ocular Hypertension
  • 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: 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: 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)
  • 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)
    Interventions:
    • Drug: Travatan
    • Drug: Placebo (Timolol Vehicle)
  • 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)
    Intervention: Drug: Cosopt
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
46
Not Provided
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • By Age
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT00471068
EMD-05-03
No
Alcon Research
Alcon Research
Not Provided
Study Director: Anna Grau Alcon Research
Alcon Research
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP