Dry EyeTURMERICNCT03265327
Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms
A study testing Oral supplement containing omega-3 and omega-6 and Oral supplement containing coconut and olive oil in people with Dry Eye, run by Nature's Way Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Oral supplement containing omega-3 and omega-6 and Oral supplement containing coconut and olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 16 Aug 2017to 27 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)
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.
- Conditions
- Dry Eye
- Being tested
- Oral supplement containing omega-3 and omega-6, Oral supplement containing coconut and olive oil
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral supplement containing omega-3 and omega-6Dietary supplement
An oral supplement containing omega-3 and omega-6
Oral supplement containing coconut and olive oilDietary supplement
An oral supplement containing coconut oil and olive oil
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil. Receives: Dietary Supplement: Oral supplement containing omega-3 and omega-6 |
| Placebo | Placebo comparator | Subjects will receive an oral supplement containing coconut oil and light olive oil. Receives: Dietary Supplement: Oral supplement containing coconut and olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At screening
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.
Measured: At 1 month
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.
Measured: At 3 months
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.
Measured: At screening
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.
Measured: At 1 month
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.
Measured: At 3 months
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.
Measured: At screening
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.
Measured: At 1 month
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.
Measured: At 3 months
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Measured: At screening
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Measured: At 1 month
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Measured: At 3 months
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.
Measured: At screening
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.
Measured: At 1 month
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.
Measured: At 3 months
Secondary outcomes (7)
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).
Measured: At screening, 1 month and 3 months
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).
Measured: At screening, 1 month and 3 months
Change in Tear meniscus height after 3 months
Measurement of tear meniscus height in mm.
Measured: At screening, 1 month and 3 months
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
Measured: At screening, 1 month and 3 months
Change in Visual acuity after 3 months
High contrast logMAR VA with computerized charts in high illumination
Measured: At screening, 1 month and 3 months
Change in Tear osmolarity after 3 months
Measure of the osmolarity of collected tears.
Measured: At screening and 3 months
Change in Omega-3 index after 3 months
Amount of EPA and DHA in erythrocytes
Measured: At screening and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start16 Aug 2017
- Primary completion27 Jun 2018
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nature's Way Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Contact Lens Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265327
- Sponsor's protocol ID
- 22309
- Acronym
- TURMERIC
- Status last verified
- Apr 2021
- First submitted
- 24 Aug 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34882608
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)
- ClinicalTrials.gov ID
- NCT03265327
- Acronym / sponsor ID
- TURMERIC / 22309
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Nature's Way CanadaIndustry (pharma, biotech, devices)
- Collaborators
- Centre for Contact Lens Research
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 27 Jun 2018 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Oral supplement containing omega-3 and omega-6Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil. |
| Placebo | Placebo comparator | Dietary Supplement: Oral supplement containing coconut and olive oilSubjects will receive an oral supplement containing coconut oil and light olive oil. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral supplement containing omega-3 and omega-6An oral supplement containing omega-3 and omega-6 | Dietary supplement | Treatment |
| Oral supplement containing coconut and olive oilAn oral supplement containing coconut oil and olive oil | Dietary supplement | Placebo |
Primary outcome
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.
7 secondary outcomes
Change in Bulbar hyperemia after 3 months
Time frame: At screening, 1 month and 3 months
Change in Limbal hyperemia after 3 months
Time frame: At screening, 1 month and 3 months
Change in Tear meniscus height after 3 months
Time frame: At screening, 1 month and 3 months
Change in Meiboscore (Arita's scale) after 3 months
Time frame: At screening, 1 month and 3 months
Change in Visual acuity after 3 months
Time frame: At screening, 1 month and 3 months
Change in Tear osmolarity after 3 months
Time frame: At screening and 3 months
Change in Omega-3 index after 3 months
Time frame: At screening and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 34882608Ng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral supplement containing omega-3 and omega-6 and Oral supplement containing coconut and olive oil in people with Dry Eye, run by Nature's Way Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) score (time frame: At screening). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03265327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.