Biochemical Factors for a Dry Eyed Population

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

50 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre for Contact Lens Research, School of Optometry

Waterloo, Ontario, N2L3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A person is eligible for inclusion in the study, for the dry eye group or control, if she:

Is Caucasian, and has full legal capacity to volunteer.
Is post-menopausal, with menses ceasing more than 12 months ago.
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)
Has read, understood and signed an information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Has clear corneas and no active ocular disease.
Has had an ocular examination in the last two years.

Exclusion criteria

Is on hormone replacement therapy (HRT).
Ceased menses due to autoimmune disorders, mumps, chemotherapy, pelvic irradiation or smoking.
Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health.
Is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuroendocrine system function.
Has undergone corneal refractive surgery.
Is aphakic.
Has any active ocular disease.
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Is participating in any other type of clinical or research study.
Is a contact lens wearer.
Has blepharitis.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

Alcon Research

Registry information

Acronym: GARNET

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Aug 30, 2007
Registry last updated: Feb 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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