Cosopt Versus Xalatan

Sponsor
Pharmaceutical Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT00273429
Collaborator
(none)
2
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: timolol maleate 0.5%
  • Drug: dorzolamide/timolol maleate fixed combination
  • Drug: latanoprost 0.005%
  • Drug: placebo
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 2005
Study Completion Date :
Dec 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Florida Eye Associates Lakeland Florida United States 33805
    2 Midwest Eye Center SC Bourbonnais Illinois United States 60914

    Sponsors and Collaborators

    • Pharmaceutical Research Network

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00273429
    Other Study ID Numbers:
    • PRN 04-015
    First Posted:
    Jan 9, 2006
    Last Update Posted:
    Jan 9, 2007
    Last Verified:
    Jan 1, 2007

    Study Results

    No Results Posted as of Jan 9, 2007