Biochemical Factors for a Dry Eyed Population (GARNET)

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00522847
First received: August 29, 2007
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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
Dry Eye

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biochemical Factors for a Dry Eyed Population

Further study details as provided by University of Waterloo:

Biospecimen Retention:   Samples Without DNA

Tears


Enrollment: 40
Study Start Date: May 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

community sample

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522847

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Craig Woods, Research Manager, CCLR
ClinicalTrials.gov Identifier: NCT00522847     History of Changes
Other Study ID Numbers: P/263/07/L
Study First Received: August 29, 2007
Last Updated: February 12, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of Waterloo:
Postmenopausal
non dry eye

ClinicalTrials.gov processed this record on July 24, 2014