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24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT00331240
Collaborator
(none)
32
Enrollment
1
Location
11.1
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular pressure control and safety of TravTim fixed combination given once in the evening with placebo once in the morning versus TravTim given once in the morning with placebo once in the evening in patients with open-angle glaucoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: travoprost/timolol fixed combination
  • Drug: placebo (artificial tears)
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Feb 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    29 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • POAG

    • Exfoliation syndrome

    Exclusion Criteria:
    • Advanced glaucoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital Thessaloniki Greece 546 36

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki

    Investigators

    • Principal Investigator: AGP Konstas, MD, PhD, Glaucoma Unit, A University Dept of Ophthalmology, AHEPA Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT00331240
    Other Study ID Numbers:
    • A1457
    First Posted:
    May 29, 2006
    Last Update Posted:
    May 12, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Glaucoma, Open-Angle
    Exfoliation Syndrome
    Timolol
    Travoprost
    Lubricant Eye Drops

    Study Results

    No Results Posted as of May 12, 2014