Biochemical Factors for a Dry Eyed Population (GARNET)

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: NCT00522847
Recruitment Status : Completed
First Posted : August 30, 2007
Last Update Posted : February 16, 2009
Alcon Research
Information provided by:
University of Waterloo

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
Dry Eye

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 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 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
community sample

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00522847

Canada, Ontario
Centre for Contact Lens Research, School of Optometry
Waterloo, Ontario, Canada, N2L3G1
Sponsors and Collaborators
University of Waterloo
Alcon Research
Principal Investigator: Desmond Fonn, M.Optom University of Waterloo

Responsible Party: Craig Woods, Research Manager, CCLR Identifier: NCT00522847     History of Changes
Other Study ID Numbers: P/263/07/L
First Posted: August 30, 2007    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

Keywords provided by University of Waterloo:
non dry eye