Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms (TURMERIC)

Nature's Way Canada

Status: Completed

Conditions: Dry Eye

Treatments: Dietary Supplement: Oral supplement containing coconut and olive oil; Dietary Supplement: Oral supplement containing omega-3 and omega-6

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03265327

22309

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.

Treatment:

Dietary Supplement: Oral supplement containing omega-3 and omega-6

Placebo

Placebo Comparator group

Description:

Subjects will receive an oral supplement containing coconut oil and light olive oil.

Treatment:

Dietary Supplement: Oral supplement containing coconut and olive oil