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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Dietary supplement: Oral supplement containing omega-3 and omega-6; Dietary supplement: Oral supplement containing coconut and olive oil

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.	Dietary supplement: Oral supplement containing omega-3 and omega-6; An oral supplement containing omega-3 and omega-6
Placebo Comparator: Placebo; Subjects will receive an oral supplement containing coconut oil and light olive oil.	Dietary supplement: Oral supplement containing coconut and olive oil; An oral supplement containing coconut oil and olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Surface Disease Index (OSDI) score	The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.	At screening
Ocular Surface Disease Index (OSDI) score	The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.	At 1 month
Ocular Surface Disease Index (OSDI) score	The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.	At 3 months
Symptom Assessment in Dry Eye (SANDE) questionnaire	The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.	At screening
Symptom Assessment in Dry Eye (SANDE) questionnaire	The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.	At 1 month
Symptom Assessment in Dry Eye (SANDE) questionnaire	The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.	At 3 months
Schirmers test	The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.	At screening
Schirmers test	The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.	At 1 month
Schirmers test	The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.	At 3 months
Objective non-invasive tear film stability (NIKBUT)	Time taken for tear film breakup as measured objectively in seconds.	At screening
Objective non-invasive tear film stability (NIKBUT)	Time taken for tear film breakup as measured objectively in seconds.	At 1 month
Objective non-invasive tear film stability (NIKBUT)	Time taken for tear film breakup as measured objectively in seconds.	At 3 months
Non-invasive tear break up time (NITBUT)	Time taken for tear film breakup as measured by a study investigator in seconds.	At screening
Non-invasive tear break up time (NITBUT)	Time taken for tear film breakup as measured by a study investigator in seconds.	At 1 month
Non-invasive tear break up time (NITBUT)	Time taken for tear film breakup as measured by a study investigator in seconds.	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bulbar hyperemia after 3 months	The redness of the bulbar conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps).	At screening, 1 month and 3 months
Change in Limbal hyperemia after 3 months	The redness of the limbal conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps).	At screening, 1 month and 3 months
Change in Tear meniscus height after 3 months	Measurement of tear meniscus height in mm.	At screening, 1 month and 3 months
Change in Meiboscore (Arita's scale) after 3 months	Graded on 0-3 scale. Grade 0: no dropout, Grade 1: < 1/3 total area dropout, Grade 2: 1/3 to 2/3 total area dropout, Grade 3: > 2/3 total area dropout	At screening, 1 month and 3 months
Change in Visual acuity after 3 months	High contrast logMAR VA with computerized charts in high illumination	At screening, 1 month and 3 months
Change in Tear osmolarity after 3 months	Measure of the osmolarity of collected tears.	At screening and 3 months
Change in Omega-3 index after 3 months	Amount of EPA and DHA in erythrocytes	At screening and 3 months

Collaborators and Investigators

• Sponsor: Nature's Way Canada
• Collaborators: Centre for Contact Lens Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2017
• Primary Completion (Actual): June 27, 2018
• Study Completion (Actual): June 27, 2018

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 22309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No