The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Objective non-invasive tear film stability (NIKBUT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
Arms & Interventions
Treatment
Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.
Intervention: Oral supplement containing omega-3 and omega-6 (Dietary Supplement)
Placebo
Subjects will receive an oral supplement containing coconut oil and light olive oil.
Intervention: Oral supplement containing coconut and olive oil (Dietary Supplement)
Outcomes
Primary Outcomes
Objective non-invasive tear film stability (NIKBUT)
Time Frame: At 3 months
Time taken for tear film breakup as measured objectively in seconds.
Non-invasive tear break up time (NITBUT)
Time Frame: At 3 months
Time taken for tear film breakup as measured by a study investigator in seconds.
Symptom Assessment in Dry Eye (SANDE) questionnaire
Time Frame: 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
Time Frame: At 3 months
The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
Schirmers test
Time Frame: 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.
Ocular Surface Disease Index (OSDI) score
Time Frame: At screening
The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
Ocular Surface Disease Index (OSDI) score
Time Frame: At 1 month
The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
Symptom Assessment in Dry Eye (SANDE) questionnaire
Time Frame: At screening
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.
Symptom Assessment in Dry Eye (SANDE) questionnaire
Time Frame: At 1 month
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.
Schirmers test
Time Frame: At screening
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.
Schirmers test
Time Frame: At 1 month
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.
Objective non-invasive tear film stability (NIKBUT)
Time Frame: At screening
Time taken for tear film breakup as measured objectively in seconds.
Objective non-invasive tear film stability (NIKBUT)
Time Frame: At 1 month
Time taken for tear film breakup as measured objectively in seconds.
Non-invasive tear break up time (NITBUT)
Time Frame: At screening
Time taken for tear film breakup as measured by a study investigator in seconds.
Non-invasive tear break up time (NITBUT)
Time Frame: At 1 month
Time taken for tear film breakup as measured by a study investigator in seconds.
Secondary Outcomes
- Change in Bulbar hyperemia 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 Omega-3 index after 3 months(At screening and 3 months)
- Change in Tear meniscus height 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 Meiboscore (Arita's scale) after 3 months(At screening, 1 month and 3 months)
- Change in Tear osmolarity after 3 months(At screening and 3 months)