Clincosm LogoSign in Get a demo

Investigation on Medical Management of Dry Eye Patients

Sponsor
National Cheng Kung University (Other)
Overall Status
Completed
CT.gov ID
NCT01942226
Collaborator
National Taiwan University Hospital (Other), Sun-Huei Tseng Eye Institute (Other), Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Tainan, Taiwan (Other), Allergan Pharmaceuticals Taiwan Co., Ltd. (Industry)
466
Enrollment
2
Locations
4
Duration (Months)
233
Patients Per Site
58.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dry eye is a common complaint in patients encountered by ophthalmologists, which may result from the inflammatory response and can occur in the absence of systemic disease. However, the management of dry eye syndrome in real setting warrants assessment but remains lacking in Taiwan. We conducted an perspective observational study to evaluate the medical management of dry eye patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    466 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Study Start Date :
    Aug 1, 2013
    Actual Primary Completion Date :
    Nov 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Artificial tears utilization patterns [within 1 month before recruitment]

    Secondary Outcome Measures

    1. Changes of dry eye symptoms, evaluated by clinicians [Baseline]

      Measured by clinical global impression (CGI)

    2. Changes of dry eye symptoms, evaluated by patients [Baseline]

      Measured by subject global assessment (SGA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have given a written informed consent

    • Clinical diagnosis of dry eye syndrome

    • Have at least one Schirmer's test positive result (less than 10mm/5min) in at least one eye within one year

    Exclusion Criteria:

    • Pregnancy

    • Cognitive or psychiatric deficit that precludes informed consent

    • Cognitive or psychiatric deficit that precludes ability to perform requirements of the investigation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun-Huei Tseng Eye Institute Tainan Taiwan 704
    2 Department of Ophthalmology, National Taiwan University Hospital Taipei Taiwan 101

    Sponsors and Collaborators

    • National Cheng Kung University
    • National Taiwan University Hospital
    • Sun-Huei Tseng Eye Institute
    • Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Tainan, Taiwan
    • Allergan Pharmaceuticals Taiwan Co., Ltd.

    Investigators

    • Principal Investigator: Yea-Huei Kao Yang, Professor, Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yea-Huei Kao Yang, Professor, National Cheng Kung University
    ClinicalTrials.gov Identifier:
    NCT01942226
    Other Study ID Numbers:
    • MODE
    First Posted:
    Sep 13, 2013
    Last Update Posted:
    Dec 9, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Yea-Huei Kao Yang, Professor, National Cheng Kung University
    Dry eye syndrome
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca

    Study Results

    No Results Posted as of Dec 9, 2013