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GARNET: Biochemical Factors for a Dry Eyed Population

Sponsor
University of Waterloo (Other)
Overall Status
Completed
CT.gov ID
NCT00522847
Collaborator
Alcon Research (Industry)
40
Enrollment
1
Location
4
Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare various symptoms and signs of dry-eye as well as stratify characteristics of the tear film in a group of dry-eyed individuals in comparison to a group of non-dry-eyed people. Dry-eye is a condition that significantly impacts the quality of life of the sufferer. These are people who are predominantly female and in the older age groups. Determining what characterises a person with dry-eyes is of importance to understanding the disease process.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Dry eye is a multifactorial disease that results in a wide variety of signs and symptoms, which are often poorly correlated. Recent work has shown that not only are there changes in the composition of the tear film (including cytokines and the presence of various mucin species and tear film proteins) but also quantifiable changes in both the structure and function of the ocular surface, including corneal sensitivity and the appearance of the epithelial cells and the sub-basal neural network. To-date, no published study has attempted to correlate various clinical and morphological changes found in dry eye with tear film and ocular surface biomarkers.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Biochemical Factors for a Dry Eyed Population
    Study Start Date :
    May 1, 2007
    Actual Primary Completion Date :
    Sep 1, 2007
    Actual Study Completion Date :
    Sep 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      50 Years to 75 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      A person is eligible for inclusion in the study, for the dry eye group or control, if she:

      1. Is Caucasian, and has full legal capacity to volunteer.

      2. Is post-menopausal, with menses ceasing more than 12 months ago.

      3. Has moderate or severe dry eye symptoms based on dry eye questionnaire and half of the time wants to use eye drops for dry eye symptoms (dry eye group)

      4. Has read, understood and signed an information consent letter.

      5. Is willing and able to follow instructions and maintain the appointment schedule.

      6. Has clear corneas and no active ocular disease.

      7. Has had an ocular examination in the last two years.

      Exclusion Criteria:

      1. Is on hormone replacement therapy (HRT).

      2. Ceased menses due to autoimmune disorders, mumps, chemotherapy, pelvic irradiation or smoking.

      3. Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health.

      4. Is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuroendocrine system function.

      5. Has undergone corneal refractive surgery.

      6. Is aphakic.

      7. Has any active ocular disease.

      8. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

      9. Is participating in any other type of clinical or research study.

      10. Is a contact lens wearer.

      11. Has blepharitis.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Centre for Contact Lens Research, School of Optometry Waterloo Ontario Canada N2L3G1

      Sponsors and Collaborators

      • University of Waterloo
      • Alcon Research

      Investigators

      • Principal Investigator: Desmond Fonn, M.Optom, University of Waterloo

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00522847
      Other Study ID Numbers:
      • P/263/07/L
      First Posted:
      Aug 30, 2007
      Last Update Posted:
      Feb 16, 2009
      Last Verified:
      Feb 1, 2009
      Keywords provided by , ,
      Postmenopausal
      non dry eye
      Additional relevant MeSH terms:
      Dry Eye Syndromes

      Study Results

      No Results Posted as of Feb 16, 2009