Dry Eye
Conditions
Brief summary
Tears play a vital role in vision. A thin layer of tears is always present to cover the surface of the eye for optimal comfort and vision. There are several layers to the tear film, and the outer most layer is comprised of lipids. This lipid layer prevents evaporation of the tears and may be disrupted in people suffering from symptoms of dry eye. Cleaning eyelids with Cliradex wipes have shown to be effective in reducing dry eye symptoms in some patients, and the purpose of this study is to evaluate the tear film lipid layer thickness before and after one months treatment with Cliradex Wipes.
Interventions
OTHERCliradex
Cliradex is simply water and 4-Terpineol, a natural organic compound found Melaleuca alternifolia. The other ingredients in Cliradex are in less than 1% of the formulation and are Glycerin, Polysorbate 20, Polysorbate 80, Carbomer, Triethanolamine.
Sponsors
Canadian Optometric Education Trust Fund (COETF)
University of Waterloo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 17 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. Have not worn contact lenses in the past month; 5. Has symptomatic dry eye with SPEED questionnaire score ≥6; 6. Corneal staining grade ≥2 on the Oxford scale.
Exclusion criteria
1. Has any known active ocular disease and/or infection; 2. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 3. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 4. Have used rewetting drops for a period of 2 days prior to screening visit; 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 enrolment by verbal confirmation at the screening visit; 7. Is aphakic; 8. Has undergone refractive error surgery; 9. Has taken part in another (pharmaceutical) research study within the last 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid layer thickness | Baseline | Lipid layer thickness measured in nm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive tear breakup time (NITBUT) | Baseline | Measurement of time taken for a dry spot to appear on the corneal surface after blinking. |
| Dry Eye Questionnaire (SPEED score) | Baseline | Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms. |
| Overall corneal staining grade | Baseline | Overall corneal staining score evaluated on a scale from 0 (none) to 5 (severe). A lower grade indicates less corneal surface desiccation. |
| Conjunctival hyperemia | Baseline | Conjunctival hyperemia evaluated on a scale from 0 (negligible) to 100 (severe). |
Countries
Canada
Outcome results
None listed