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

Dry Eye Clinical Trial

— TURMERIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265327
• Other study ID #: 22309
• Status: Completed
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: June 27, 2018

Study information

• Verified date: April 2021
• Source: Nature's Way Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 27, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Dietary Supplement:
• Oral supplement containing omega-3 and omega-6
An oral supplement containing omega-3 and omega-6
• Oral supplement containing coconut and olive oil
An oral supplement containing coconut oil and olive oil

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Nature's Way Canada	Centre for Contact Lens Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Objective non-invasive tear film stability (NIKBUT)	Time taken for tear film breakup as measured objectively in seconds.	At screening
Primary	Objective non-invasive tear film stability (NIKBUT)	Time taken for tear film breakup as measured objectively in seconds.	At 1 month
Primary	Objective non-invasive tear film stability (NIKBUT)	Time taken for tear film breakup as measured objectively in seconds.	At 3 months
Primary	Non-invasive tear break up time (NITBUT)	Time taken for tear film breakup as measured by a study investigator in seconds.	At screening
Primary	Non-invasive tear break up time (NITBUT)	Time taken for tear film breakup as measured by a study investigator in seconds.	At 1 month
Primary	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	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
Secondary	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
Secondary	Change in Tear meniscus height after 3 months	Measurement of tear meniscus height in mm.	At screening, 1 month and 3 months
Secondary	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
Secondary	Change in Visual acuity after 3 months	High contrast logMAR VA with computerized charts in high illumination	At screening, 1 month and 3 months
Secondary	Change in Tear osmolarity after 3 months	Measure of the osmolarity of collected tears.	At screening and 3 months
Secondary	Change in Omega-3 index after 3 months	Amount of EPA and DHA in erythrocytes	At screening and 3 months