Status:
COMPLETED
Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms
Lead Sponsor:
Nature's Way Canada
Collaborating Sponsors:
Centre for Contact Lens Research
Conditions:
Dry Eye
Eligibility:
All Genders
19+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Is over 19 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and anticipated to be able to comply with the daily intake of liquid oil supplements (one teaspoon per day for three months);
- Is willing and able to follow instructions and maintain the appointment schedule;
- Exhibit moderate ocular dryness symptoms, defined as:
- A score of ≥23 on the Ocular Surface Disease Index (OSDI, (Allergan Inc., Irvine, CA)) questionnaire;
- Currently uses, or feels the need to use eye drops to relieve symptoms of dryness.
Exclusion
- Is participating in any concurrent clinical or research study;
- Has any known active\* ocular disease and/or infection;
- Currently wears, or has worn contact lenses in the past 3 months;
- Has sensitivity or an allergy to products that contain fish, soy, coconut oil or olive oil;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- 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;
- Is currently taking, or has used, any omega-3 or omega-6 supplements in the last three months;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment;
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Contact Lens Research;
- Has taken part in another (pharmaceutical) research study within the last 30 days;
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2018
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03265327
Start Date
August 16 2017
End Date
June 27 2018
Last Update
April 29 2021
Active Locations (1)
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1
Centre for Contact Lens Research
Waterloo, Ontario, Canada, N2L 3G1