Overview

A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)

Status:
Completed

Trial end date:
2014-11-01

Target enrollment:
0

Participant gender:
All

Summary

Dry eye is a very common condition that most often affects women and the elderly, and can be caused when the eyes do not produce enough tears, or when the tears evaporate too quickly. Although there isn't a simple cure for dry eye, there are numerous products on the market that attempt to help relieve some of the discomfort caused by this condition. Some of these products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications. The purpose of this study is to evaluate the performance of a combination of TheraTears® products, and to compare them with the product(s) you have been using.

Phase:

Phase 4

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

University of Waterloo

Collaborator:

Advanced Vision Research

Treatments:

alpha-Tocopherol
Carboxymethylcellulose Sodium
Lubricant Eye Drops
Ophthalmic Solutions
Tetrahydrozoline
Tocopherols
Vitamin E

Criteria

Inclusion Criteria:

1. Is between 18 and 65 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

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

4. Exhibits symptoms of dry eye for at least 3 months;

5. Has an OSDI score of ≥ 23;

6. Is currently on a non-omega 3 dry eye treatment regimen that, at the minimum consists
of instilling artificial tears at least once a day for the past 3 months;

7. Has an average non-invasive tear breakup time ≤ 5.00 seconds in at least one eye.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection and/or allergies;

* For the purposes of study, active ocular disease is defined as infection or
inflammation which requires therapeutic treatment. Lid abnormalities (blepharitis,
meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye
are typical findings and are not considered active ocular disease. Neovascularization
and corneal scars are the result of previous hypoxia, infection or inflammation and
are therefore not active.

3. Has a systemic condition that in the opinion of the investigator may affect a study
outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator
may affect a study outcome variable;

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

6. Is pregnant, lactating or planning a pregnancy at the time of enrollment, as
determined verbally;

7. Is aphakic;

8. Has undergone refractive error surgery;

9. Has taken part in another (pharmaceutical) research study within the last 30 days;

10. Has worn contact lenses within the past 5 years;

11. Is currently using or have used omega 3 supplements in the past 3 months.