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

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oral supplement containing omega-3 and omega-6
Oral supplement containing coconut and olive oil
Sponsored by
Nature's Way Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Centre for Contact Lens Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.

Subjects will receive an oral supplement containing coconut oil and light olive oil.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.

Secondary Outcome Measures

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).
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).
Change in Tear meniscus height after 3 months
Measurement of tear meniscus height in mm.
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
Change in Visual acuity after 3 months
High contrast logMAR VA with computerized charts in high illumination
Change in Tear osmolarity after 3 months
Measure of the osmolarity of collected tears.
Change in Omega-3 index after 3 months
Amount of EPA and DHA in erythrocytes

Full Information

First Posted
August 24, 2017
Last Updated
April 27, 2021
Sponsor
Nature's Way Canada
Collaborators
Centre for Contact Lens Research
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1. Study Identification

Unique Protocol Identification Number
NCT03265327
Brief Title
Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms
Acronym
TURMERIC
Official Title
The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
June 27, 2018 (Actual)
Study Completion Date
June 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nature's Way Canada
Collaborators
Centre for Contact Lens Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive an oral supplement containing coconut oil and light olive oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral supplement containing omega-3 and omega-6
Intervention Description
An oral supplement containing omega-3 and omega-6
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral supplement containing coconut and olive oil
Intervention Description
An oral supplement containing coconut oil and olive oil
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index (OSDI) score
Description
The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
Time Frame
At screening
Title
Ocular Surface Disease Index (OSDI) score
Description
The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
Time Frame
At 1 month
Title
Ocular Surface Disease Index (OSDI) score
Description
The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
Time Frame
At 3 months
Title
Symptom Assessment in Dry Eye (SANDE) questionnaire
Description
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.
Time Frame
At screening
Title
Symptom Assessment in Dry Eye (SANDE) questionnaire
Description
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.
Time Frame
At 1 month
Title
Symptom Assessment in Dry Eye (SANDE) questionnaire
Description
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.
Time Frame
At 3 months
Title
Schirmers test
Description
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.
Time Frame
At screening
Title
Schirmers test
Description
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.
Time Frame
At 1 month
Title
Schirmers test
Description
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.
Time Frame
At 3 months
Title
Objective non-invasive tear film stability (NIKBUT)
Description
Time taken for tear film breakup as measured objectively in seconds.
Time Frame
At screening
Title
Objective non-invasive tear film stability (NIKBUT)
Description
Time taken for tear film breakup as measured objectively in seconds.
Time Frame
At 1 month
Title
Objective non-invasive tear film stability (NIKBUT)
Description
Time taken for tear film breakup as measured objectively in seconds.
Time Frame
At 3 months
Title
Non-invasive tear break up time (NITBUT)
Description
Time taken for tear film breakup as measured by a study investigator in seconds.
Time Frame
At screening
Title
Non-invasive tear break up time (NITBUT)
Description
Time taken for tear film breakup as measured by a study investigator in seconds.
Time Frame
At 1 month
Title
Non-invasive tear break up time (NITBUT)
Description
Time taken for tear film breakup as measured by a study investigator in seconds.
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Change in Bulbar hyperemia after 3 months
Description
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).
Time Frame
At screening, 1 month and 3 months
Title
Change in Limbal hyperemia after 3 months
Description
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).
Time Frame
At screening, 1 month and 3 months
Title
Change in Tear meniscus height after 3 months
Description
Measurement of tear meniscus height in mm.
Time Frame
At screening, 1 month and 3 months
Title
Change in Meiboscore (Arita's scale) after 3 months
Description
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
Time Frame
At screening, 1 month and 3 months
Title
Change in Visual acuity after 3 months
Description
High contrast logMAR VA with computerized charts in high illumination
Time Frame
At screening, 1 month and 3 months
Title
Change in Tear osmolarity after 3 months
Description
Measure of the osmolarity of collected tears.
Time Frame
At screening and 3 months
Title
Change in Omega-3 index after 3 months
Description
Amount of EPA and DHA in erythrocytes
Time Frame
At screening and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
Centre for Contact Lens Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34882608
Citation
Ng A, Woods J, Jahn T, Jones LW, Sullivan Ritter J. Effect of a Novel Omega-3 and Omega-6 Fatty Acid Supplement on Dry Eye Disease: A 3-month Randomized Controlled Trial. Optom Vis Sci. 2022 Jan 1;99(1):67-75. doi: 10.1097/OPX.0000000000001826.
Results Reference
derived

Learn more about this trial

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

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