Dry Eye Syndromes
Conditions
Brief 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.
Interventions
DRUGTheraTears® Lubricant Eye Drop
DRUGTheraTears® preservative-free single-use containers
DIETARY_SUPPLEMENTTheraTears® Nutrition
OTHERTheraTears® TheraLid® Eyelid Cleanser
Sponsors
Advanced Vision Research
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change over time of OSDI score | At screening, 2 weeks, 1 month and 3 months | Ocular Surface Disease Index (OSDI) questionnaire score |
| Change over time of Visual analogue scores | At screening, 2 weeks, 1 month and 3 months | — |
| Change over time of Tear osmolarity | At screening, 1 month and 3 months | — |
| Change over time of Tear film breakup time | At screening, 1 month and 3 months | — |
| Change over time of Corneal staining | At screening, 1 month and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change over time of Lid wiper epitheliopathy | At screening, 1 month and 3 months |
| Change over time of Schirmer's I scores | At screening, 1 month and 3 months |
| Change over time of Meibomian gland expressibility | At screening, 1 month and 3 months |
| Change over time of Meibum quality | At screening, 1 month and 3 months |
| Change over time of Tear film lipid layer thickness | At screening, 1 month and 3 months |
| Change over time of Tear meniscus height | At screening, 1 month and 3 months |
Countries
Canada
Outcome results
None listed