Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT03265327
Eligibility Criteria:
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;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03265327
Study Brief:
Protocol Section:
NCT03265327