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

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Dietary Supplement: Oral supplement containing coconut and olive oil; Dietary Supplement: Oral supplement containing omega-3 and omega-6

• Registration Number: NCT03265327
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-16
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Primary Completion: 2018-06-27
• Study Completion: 2018-06-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Oral supplement containing coconut and olive oil	Subjects will receive an oral supplement containing coconut oil and light olive oil.
Treatment	Oral supplement containing omega-3 and omega-6	Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.

Primary Outcome Measures

Name	Time	Method
Objective non-invasive tear film stability (NIKBUT)	At 3 months	Time taken for tear film breakup as measured objectively in seconds.
Non-invasive tear break up time (NITBUT)	At 3 months	Time taken for tear film breakup as measured by a study investigator in seconds.
Symptom Assessment in Dry Eye (SANDE) questionnaire	At 3 months	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.
Ocular Surface Disease Index (OSDI) score	At 3 months	The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
Schirmers test	At 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Bulbar hyperemia after 3 months	At screening, 1 month and 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).
Change in Visual acuity after 3 months	At screening, 1 month and 3 months	High contrast logMAR VA with computerized charts in high illumination
Change in Omega-3 index after 3 months	At screening and 3 months	Amount of EPA and DHA in erythrocytes
Change in Tear meniscus height after 3 months	At screening, 1 month and 3 months	Measurement of tear meniscus height in mm.
Change in Limbal hyperemia after 3 months	At screening, 1 month and 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).
Change in Meiboscore (Arita's scale) after 3 months	At screening, 1 month and 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
Change in Tear osmolarity after 3 months	At screening and 3 months	Measure of the osmolarity of collected tears.

Trial Locations

Locations (1)

Centre for Contact Lens Research; 🇨🇦 Waterloo, Ontario, Canada