Dry Eye
Conditions
Brief summary
This study will investigate the effectiveness of two oral supplements on the ocular signs and symptoms in symptomatic dry eye patients. Eligible participants will be given one of two oral supplements to take once a day for up to three months.
Interventions
DIETARY_SUPPLEMENTOral supplement containing omega-3 and omega-6
An oral supplement containing omega-3 and omega-6
DIETARY_SUPPLEMENTOral supplement containing coconut and olive oil
An oral supplement containing coconut oil and olive oil
Sponsors
Centre for Contact Lens Research
Nature's Way Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is over 19 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and anticipated to be able to comply with the daily intake of liquid oil supplements (one teaspoon per day for three months); 4. Is willing and able to follow instructions and maintain the appointment schedule; 5. Exhibit moderate ocular dryness symptoms, defined as: 1. A score of ≥23 on the Ocular Surface Disease Index (OSDI, (Allergan Inc., Irvine, CA)) questionnaire; 2. Currently uses, or feels the need to use eye drops to relieve symptoms of dryness.
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Has any known active\* ocular disease and/or infection; 3. Currently wears, or has worn contact lenses in the past 3 months; 4. Has sensitivity or an allergy to products that contain fish, soy, coconut oil or olive oil; 5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 6. Is using any systemic or topical medications (including topical corticosteroids/NSAIDs or glaucoma medications) that in the opinion of the investigator may affect a study outcome variable; 7. Is currently taking, or has used, any omega-3 or omega-6 supplements in the last three months; 8. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 9. Is pregnant, lactating or planning a pregnancy at the time of enrolment; 10. Is aphakic; 11. Has undergone refractive error surgery; 12. Is an employee of the Centre for Contact Lens Research; 13. Has taken part in another (pharmaceutical) research study within the last 30 days;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) score | At screening | The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness. |
| Symptom Assessment in Dry Eye (SANDE) questionnaire | At screening | The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale. |
| Schirmers test | At screening | The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm. |
| Objective non-invasive tear film stability (NIKBUT) | At screening | Time taken for tear film breakup as measured objectively in seconds. |
| Non-invasive tear break up time (NITBUT) | At screening | Time taken for tear film breakup as measured by a study investigator in seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear osmolarity after 3 months | At screening and 3 months | Measure of the osmolarity of collected tears. |
| Change in Bulbar hyperemia after 3 months | At screening, 1 month and 3 months | The redness of the bulbar conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps). |
| Change in Omega-3 index after 3 months | At screening and 3 months | Amount of EPA and DHA in erythrocytes |
| Change in Limbal hyperemia after 3 months | At screening, 1 month and 3 months | The redness of the limbal conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps). |
| Change in Tear meniscus height after 3 months | At screening, 1 month and 3 months | Measurement of tear meniscus height in mm. |
| Change in Meiboscore (Arita's scale) after 3 months | At screening, 1 month and 3 months | Graded on 0-3 scale. Grade 0: no dropout, Grade 1: \< 1/3 total area dropout, Grade 2: 1/3 to 2/3 total area dropout, Grade 3: \> 2/3 total area dropout |
| Change in Visual acuity after 3 months | At screening, 1 month and 3 months | High contrast logMAR VA with computerized charts in high illumination |
Countries
Canada
Outcome results
None listed