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

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ClinicalTrials.gov Identifier: NCT03265327
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Centre for Contact Lens Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Dietary Supplement: Oral supplement containing omega-3 and omega-6 Dietary Supplement: Oral supplement containing coconut and olive oil Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Objective non-invasive tear film stability (NIKBUT) [ Time Frame: At screening ]
    Time taken for tear film breakup as measured objectively in seconds.

  11. Objective non-invasive tear film stability (NIKBUT) [ Time Frame: At 1 month ]
    Time taken for tear film breakup as measured objectively in seconds.

  12. Objective non-invasive tear film stability (NIKBUT) [ Time Frame: At 3 months ]
    Time taken for tear film breakup as measured objectively in seconds.

  13. 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.

  14. 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.

  15. 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.


Secondary Outcome Measures :
  1. Change in Bulbar hyperemia after 3 months [ Time Frame: 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).

  2. Change in Limbal hyperemia after 3 months [ Time Frame: 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).

  3. Change in Tear meniscus height after 3 months [ Time Frame: At screening, 1 month and 3 months ]
    Measurement of tear meniscus height in mm.

  4. Change in Meiboscore (Arita's scale) after 3 months [ Time Frame: 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

  5. Change in Visual acuity after 3 months [ Time Frame: At screening, 1 month and 3 months ]
    High contrast logMAR VA with computerized charts in high illumination

  6. Change in Tear osmolarity after 3 months [ Time Frame: At screening and 3 months ]
    Measure of the osmolarity of collected tears.

  7. Change in Omega-3 index after 3 months [ Time Frame: At screening and 3 months ]
    Amount of EPA and DHA in erythrocytes



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 using ocular lubricating drops at least once per day for, at least, the past 3 months;

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265327


Contacts
Contact: Jill Woods, MCOptom 519-888-4567 ext 36743 jwoods@uwaterloo.ca

Locations
Canada, Ontario
Centre for Contact Lens Research Recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Jill Woods, MCOptom    519-888-4567 ext 36743    jwoods@uwaterloo.ca   
Principal Investigator: Lyndon Jones, PhD, FCOptom         
Sponsors and Collaborators
Nature's Way Canada
Centre for Contact Lens Research

Responsible Party: Nature's Way Canada
ClinicalTrials.gov Identifier: NCT03265327     History of Changes
Other Study ID Numbers: 22309
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases