Clinical trial NCT03265327: Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms
Official title: The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Nature's Way Canada
Sponsor class: INDUSTRY
Collaborators: name: Centre for Contact Lens Research
First posted: 2017-08-29
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI) score
timeFrame: At screening
measure: Ocular Surface Disease Index (OSDI) score
timeFrame: At 1 month
measure: Ocular Surface Disease Index (OSDI) score
timeFrame: At 3 months
measure: Symptom Assessment in Dry Eye (SANDE) questionnaire
timeFrame: At screening
measure: Symptom Assessment in Dry Eye (SANDE) questionnaire
timeFrame: At 1 month
measure: Symptom Assessment in Dry Eye (SANDE) questionnaire
timeFrame: At 3 months
measure: Schirmers test
timeFrame: At screening
measure: Schirmers test
timeFrame: At 1 month
measure: Schirmers test
timeFrame: At 3 months
measure: Objective non-invasive tear film stability (NIKBUT)
timeFrame: At screening
measure: Objective non-invasive tear film stability (NIKBUT)
timeFrame: At 1 month
measure: Objective non-invasive tear film stability (NIKBUT)
timeFrame: At 3 months
measure: Non-invasive tear break up time (NITBUT)
timeFrame: At screening
measure: Non-invasive tear break up time (NITBUT)
timeFrame: At 1 month
measure: Non-invasive tear break up time (NITBUT)
timeFrame: At 3 months
Secondary outcomes:
measure: Change in Bulbar hyperemia after 3 months
timeFrame: At screening, 1 month and 3 months
measure: Change in Limbal hyperemia after 3 months
timeFrame: At screening, 1 month and 3 months
measure: Change in Tear meniscus height after 3 months
timeFrame: At screening, 1 month and 3 months
measure: Change in Meiboscore (Arita's scale) after 3 months
timeFrame: At screening, 1 month and 3 months
measure: Change in Visual acuity after 3 months
timeFrame: At screening, 1 month and 3 months
measure: Change in Tear osmolarity after 3 months
timeFrame: At screening and 3 months
measure: Change in Omega-3 index after 3 months
timeFrame: At screening and 3 months
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research
state: Ontario
Study officials:
References:
citation: Ng A, Woods J, Jahn T, Jones LW, Sullivan Ritter J. Effect of a Novel Omega-3 and Omega-6 Fatty Acid Supplement on Dry Eye Disease: A 3-month Randomized Controlled Trial. Optom Vis Sci. 2022 Jan 1;99(1):67-75. doi: 10.1097/OPX.0000000000001826.