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

April 27, 2021 updated by: Nature's Way Canada

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Contact Lens Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At screening
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.
At 1 month
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.
At 3 months
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.
At screening
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.
At 1 month
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.
At 3 months
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.
At screening
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.
At 1 month
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.
At 3 months
Objective non-invasive tear film stability (NIKBUT)
Time Frame: At screening
Time taken for tear film breakup as measured objectively in seconds.
At screening
Objective non-invasive tear film stability (NIKBUT)
Time Frame: At 1 month
Time taken for tear film breakup as measured objectively in seconds.
At 1 month
Objective non-invasive tear film stability (NIKBUT)
Time Frame: At 3 months
Time taken for tear film breakup as measured objectively in seconds.
At 3 months
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.
At screening
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.
At 1 month
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.
At 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
At screening, 1 month and 3 months
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).
At screening, 1 month and 3 months
Change in Tear meniscus height after 3 months
Time Frame: At screening, 1 month and 3 months
Measurement of tear meniscus height in mm.
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
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
At screening, 1 month and 3 months
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
At screening, 1 month and 3 months
Change in Tear osmolarity after 3 months
Time Frame: At screening and 3 months
Measure of the osmolarity of collected tears.
At screening and 3 months
Change in Omega-3 index after 3 months
Time Frame: At screening and 3 months
Amount of EPA and DHA in erythrocytes
At screening and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nature's Way Canada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Contact Lens Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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