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

The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)

Sponsors

Lead Sponsor: Nature's Way Canada

Collaborator: Centre for Contact Lens Research

Source Nature's Way Canada
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.

Overall Status Completed
Start Date 2017-08-16
Completion Date 2018-06-27
Primary Completion Date 2018-06-27
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Ocular Surface Disease Index (OSDI) score At screening
Ocular Surface Disease Index (OSDI) score At 1 month
Ocular Surface Disease Index (OSDI) score At 3 months
Symptom Assessment in Dry Eye (SANDE) questionnaire At screening
Symptom Assessment in Dry Eye (SANDE) questionnaire At 1 month
Symptom Assessment in Dry Eye (SANDE) questionnaire At 3 months
Schirmers test At screening
Schirmers test At 1 month
Schirmers test At 3 months
Objective non-invasive tear film stability (NIKBUT) At screening
Objective non-invasive tear film stability (NIKBUT) At 1 month
Objective non-invasive tear film stability (NIKBUT) At 3 months
Non-invasive tear break up time (NITBUT) At screening
Non-invasive tear break up time (NITBUT) At 1 month
Non-invasive tear break up time (NITBUT) At 3 months
Secondary Outcome
Measure Time Frame
Change in Bulbar hyperemia after 3 months At screening, 1 month and 3 months
Change in Limbal hyperemia after 3 months At screening, 1 month and 3 months
Change in Tear meniscus height after 3 months At screening, 1 month and 3 months
Change in Meiboscore (Arita's scale) after 3 months At screening, 1 month and 3 months
Change in Visual acuity after 3 months At screening, 1 month and 3 months
Change in Tear osmolarity after 3 months At screening and 3 months
Change in Omega-3 index after 3 months At screening and 3 months
Enrollment 63
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Oral supplement containing omega-3 and omega-6

Description: An oral supplement containing omega-3 and omega-6

Arm Group Label: Treatment

Intervention Type: Dietary Supplement

Intervention Name: Oral supplement containing coconut and olive oil

Description: An oral supplement containing coconut oil and olive oil

Arm Group Label: Placebo

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;

Gender:

All

Minimum Age:

19 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Location
Facility: Centre for Contact Lens Research
Location Countries

Canada

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment

Type: Experimental

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

Label: Placebo

Type: Placebo Comparator

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

Acronym TURMERIC
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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