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Cosopt Versus Xalatan

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. Identifier: NCT00273429
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : January 9, 2007
Information provided by:
Pharmaceutical Research Network

Tracking Information
First Submitted Date  ICMJE January 6, 2006
First Posted Date  ICMJE January 9, 2006
Last Update Posted Date January 9, 2007
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Cosopt Versus Xalatan
Official Title  ICMJE Not Provided
Brief Summary To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Open-Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: timolol maleate 0.5%
  • Drug: dorzolamide/timolol maleate fixed combination
  • Drug: latanoprost 0.005%
  • Drug: placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion
  • intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H
  • ETDRS visual acuity must be 1.0 or better in both eyes

Exclusion Criteria:

  • any contraindications to study medications
  • any anticipated change in systemic hypertensive therapy during the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00273429
Other Study ID Numbers  ICMJE PRN 04-015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pharmaceutical Research Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William C. Stewart, MD Pharmaceutical Research Network, LLC
Principal Investigator: Jay Mulaney, MD Central Florida Eye Associates
Principal Investigator: Sriram Sonty, MD, FACS Midwest Eye Center SC
PRS Account Pharmaceutical Research Network
Verification Date January 2007

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