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Completed

NCT Number: NCT03265327

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Oral supplement containing omega-3 and omega-6

Dietary Supplement

An oral supplement containing omega-3 and omega-6

Oral supplement containing coconut and olive oil

Dietary Supplement

An oral supplement containing coconut oil and olive oil

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nature's Way Canada

Industry

Collaborators

  • Centre for Contact Lens Research

Registry information

Official study title

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

Acronym: TURMERIC

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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