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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye

Intervention / Treatment
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* Dietary Supplement: Oral supplement containing omega-3 and omega-6
* Dietary Supplement: Oral supplement containing coconut and olive oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is over 19 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and anticipated to be able to comply with the daily intake of liquid oil supplements (one teaspoon per day for three months); Is willing and able to follow instructions and maintain the appointment schedule; Exhibit moderate ocular dryness symptoms, defined as: A score of ≥23 on the Ocular Surface Disease Index (OSDI, (Allergan Inc., Irvine, CA)) questionnaire; Currently uses, or feels the need to use eye drops to relieve symptoms of dryness. Exclusion Criteria: Is participating in any concurrent clinical or research study; Has any known active* ocular disease and/or infection; Currently wears, or has worn contact lenses in the past 3 months; Has sensitivity or an allergy to products that contain fish, soy, coconut oil or olive oil; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 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; Is currently taking, or has used, any omega-3 or omega-6 supplements in the last three months; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment; Is aphakic; Has undergone refractive error surgery; Is an employee of the Centre for Contact Lens Research; Has taken part in another (pharmaceutical) research study within the last 30 days;

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* An oral supplement containing omega-3 and omega-6<br>|
| Placebo Comparator: Placebo<br>Subjects will receive an oral supplement containing coconut oil and light olive oil. | Dietary Supplement: Oral supplement containing coconut and olive oil<br>* An oral supplement containing coconut oil and olive oil<br>|

What is the study measuring?
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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 |