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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 : Completed
First Posted : August 29, 2017
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Centre for Contact Lens Research
Information provided by (Responsible Party):
Nature's Way Canada

Tracking Information
First Submitted Date  ICMJE August 24, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date August 23, 2018
Actual Study Start Date  ICMJE August 16, 2017
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03265327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • 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).
  • 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).
  • Change in Tear meniscus height after 3 months [ Time Frame: At screening, 1 month and 3 months ]
    Measurement of tear meniscus height in mm.
  • 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
  • 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
  • Change in Tear osmolarity after 3 months [ Time Frame: At screening and 3 months ]
    Measure of the osmolarity of collected tears.
  • Change in Omega-3 index after 3 months [ Time Frame: At screening and 3 months ]
    Amount of EPA and DHA in erythrocytes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms
Official Title  ICMJE The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Dietary Supplement: Oral supplement containing omega-3 and omega-6
    An oral supplement containing omega-3 and omega-6
  • Dietary Supplement: Oral supplement containing coconut and olive oil
    An oral supplement containing coconut oil and olive oil
Study Arms  ICMJE
  • Experimental: Treatment
    Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.
    Intervention: Dietary Supplement: Oral supplement containing omega-3 and omega-6
  • Placebo Comparator: Placebo
    Subjects will receive an oral supplement containing coconut oil and light olive oil.
    Intervention: Dietary Supplement: Oral supplement containing coconut and olive oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2018)
63
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2017)
60
Actual Study Completion Date  ICMJE June 27, 2018
Actual Primary Completion Date June 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03265327
Other Study ID Numbers  ICMJE 22309
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nature's Way Canada
Study Sponsor  ICMJE Nature's Way Canada
Collaborators  ICMJE Centre for Contact Lens Research
Investigators  ICMJE Not Provided
PRS Account Nature's Way Canada
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP