Back to resultsThe Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Supplement
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Nutraceutical supplement
Eligibility Criteria
Inclusion Criteria:
- Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- Be at least 18 years old;
- Have symptoms of ocular discomfort as measured with the Ocular Surface Disease Index (OSDI) score of >12 at the Baseline visit;
- Willing to comply with the dosage and study visit schedule as directed by the investigator;
- No contact lens wear in the last 30 days and willing to refrain from contact lens wear for the duration of the study;
- No planned changes to diet and willing not to substantially alter their usual diet for the duration of the study, including their typical intake of fish;
- Willingness to notify the study investigator if instructed to alter their diet by health/medical practitioner;
- Willing to continue using any artificial tear supplements at the same frequency throughout the study, as used prior to the study
- Have health and ocular health findings which would not prevent the participant from safely ingesting dietary supplementation with combination omega oils
Exclusion Criteria:
- Any systemic disease that would preclude participants from safely ingesting dietary supplementation with combination omega oils;
- Self-reported allergy/sensitivity to any of the study product ingredients;
- Use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil) up to 12 weeks prior to the start of the study;
Use of any of the following medications (including steroids) up to 12 weeks prior to start of the study or during the course of the study:
- Ocular medication, category S3 and above;
- Any systemic or topical medications that will affect ocular physiology e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone and antihistamine medications such as Claritine;
- Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis and systemic lupus erythematosis;
- Epilepsy or history of migraines exacerbated by flashing, strobe-like lights;
- Eye surgery within 6 months immediately prior to enrolment for this study;
- Rigid or soft contact lens wearer, including orthokeratology in the last 30 days;
- Previous corneal refractive surgery;
- Pregnancy or breastfeeding.
Sites / Locations
- School of Optometry and Vision Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Supplement
Placebo
Arm Description
Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids
Polyethylene glycol, Oleic acid, Propylene glycol
Outcomes
Primary Outcome Measures
Subjective Ocular Symptoms
Measured using the Ocular Surface Disease Index questionnaire. Ocular surface disease index is assessed on a scale of 0 to 100 with higher score representing greater disability. Scores can range from 10 to 100.
Subjective Ocular Comfort
Measured using the Ocular Comfort Index questionnaire. Ocular comfort index questionnaire score range from 0 to 72. Lowest slow indicates better subjective symptoms.
Subjective Ocular Dryness
Measured using the Dry Eye Questionnaire 5. Dry eye questionnaire 5 score ranges from 0 to 22.
Lower score represents better outcome.
Secondary Outcome Measures
Non-invasive Tear Film Break-up Time
Measured in seconds using the Oculus Keratograph. Higher value represents better outcome.
Tear Evaporation Rate
Measured in g.m^2.h using the Vapometer
Tear Meniscus Height
Measured in millimeters using the Oculus Keratograph 5M
Tear Volume
Measured in millimeters using phenol red thread tests
Tear Film Lipid Layer Thickness
Measured in nanometers using the LipiView ocular surface interferometer
Full Information
NCT ID
NCT03141931
First Posted
February 6, 2017
Last Updated
May 27, 2020
Sponsor
The University of New South Wales
1. Study Identification
Unique Protocol Identification Number
NCT03141931
Brief Title
The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye
Official Title
The Effects of Dietary Supplementation With a Combination of Flaxseed Oil, Borage Oil and Fish Oil Omega-3 Fatty Acids on Ocular Comfort Including Symptoms of Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
October 19, 2018 (Actual)
Study Completion Date
October 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
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
The aim of this study is to compare ocular symptoms and signs when the test nutraceutical formulation (combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids) is consumed daily over a 3 month period, with a control capsule that contains polyethylene glycol (PEG), oleic acid and propylene glycol, which are found in many pharmaceutical products and are generally considered to be biologically inert and safe. There is good evidence that the consumption of oily fish has a protective effect against dry eye, and other studies have provided evidence of the beneficial effect of supplementation with omega-3 essential fatty acids in the treatment of dry eye disease. However, there have been limited well designed clinical trials investigating the potential for nutraceutical dietary supplementation to impact ocular comfort. To date, no controlled, randomised clinical trials have been conducted to evaluate the test nutraceutical formulation. Therefore, the purpose of this study is to conduct a randomized, placebo-controlled, double-masked study to investigate the effects of dietary supplementation with a combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids on ocular comfort including signs and symptoms of dry eye.
Detailed Description
This study will be a prospective, randomised, placebo-controlled, double masked study conducted over a 3-month period. One hundred and thirty-eight (138) participants who meet the inclusion / exclusion criteria and give informed consent will be randomised to either the test capsules containing a combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids or placebo capsules, identical in appearance, containing polyethylene glycol, oleic acid and propylene glycol (found in many pharmaceutical products and considered to be biologically inert and safe) to be taken by mouth three times daily for 40 days, and then twice daily thereafter for approximately 50 days. Every effort will be made to stratify enrolment by disease severity to ensure participants with mild, moderate and severe dry eye are represented in the study population. Stratification will be in a 2:2:1 fashion i.e. OSDI score >12 (55 participants), OSDI score >20 (55 participants) and OSDI score >45 (28 participants). Participants will be stratified according to dry eye severity prior to randomisation. There will be a total of 3 scheduled study visits over a period of approximately 3 months - Day 1, 1 month and 3 months. Ocular comfort and symptoms of dry eye will be assessed via questionnaires. The tear film and ocular surface will be assessed using specialised instruments including the slit lamp biomicroscope, Lipiview Ocular Surface Interferometer, Vapometer and Oculus Keratograph 5M, and stains. Safety will be assessed through measurement of vision, ocular redness and evaluation of the ocular surface using the slit lamp biomicroscope. Those participants who meet the eligibility criteria will be randomly allocated to either the test or control capsules. An adequate supply of capsules will be dispensed to last until the next Participants will be instructed to ingest one capsule three times daily with meals for 40 days, and then two times daily until their final 3 month study visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Nutraceutical supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double masked
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplement
Arm Type
Experimental
Arm Description
Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Polyethylene glycol, Oleic acid, Propylene glycol
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplement
Intervention Description
Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)
Primary Outcome Measure Information:
Title
Subjective Ocular Symptoms
Description
Measured using the Ocular Surface Disease Index questionnaire. Ocular surface disease index is assessed on a scale of 0 to 100 with higher score representing greater disability. Scores can range from 10 to 100.
Time Frame
3 months
Title
Subjective Ocular Comfort
Description
Measured using the Ocular Comfort Index questionnaire. Ocular comfort index questionnaire score range from 0 to 72. Lowest slow indicates better subjective symptoms.
Time Frame
3 months
Title
Subjective Ocular Dryness
Description
Measured using the Dry Eye Questionnaire 5. Dry eye questionnaire 5 score ranges from 0 to 22.
Lower score represents better outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Non-invasive Tear Film Break-up Time
Description
Measured in seconds using the Oculus Keratograph. Higher value represents better outcome.
Time Frame
3 months
Title
Tear Evaporation Rate
Description
Measured in g.m^2.h using the Vapometer
Time Frame
3 months
Title
Tear Meniscus Height
Description
Measured in millimeters using the Oculus Keratograph 5M
Time Frame
3 months
Title
Tear Volume
Description
Measured in millimeters using phenol red thread tests
Time Frame
3 months
Title
Tear Film Lipid Layer Thickness
Description
Measured in nanometers using the LipiView ocular surface interferometer
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Be at least 18 years old;
Have symptoms of ocular discomfort as measured with the Ocular Surface Disease Index (OSDI) score of >12 at the Baseline visit;
Willing to comply with the dosage and study visit schedule as directed by the investigator;
No contact lens wear in the last 30 days and willing to refrain from contact lens wear for the duration of the study;
No planned changes to diet and willing not to substantially alter their usual diet for the duration of the study, including their typical intake of fish;
Willingness to notify the study investigator if instructed to alter their diet by health/medical practitioner;
Willing to continue using any artificial tear supplements at the same frequency throughout the study, as used prior to the study
Have health and ocular health findings which would not prevent the participant from safely ingesting dietary supplementation with combination omega oils
Exclusion Criteria:
Any systemic disease that would preclude participants from safely ingesting dietary supplementation with combination omega oils;
Self-reported allergy/sensitivity to any of the study product ingredients;
Use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil) up to 12 weeks prior to the start of the study;
Use of any of the following medications (including steroids) up to 12 weeks prior to start of the study or during the course of the study:
Ocular medication, category S3 and above;
Any systemic or topical medications that will affect ocular physiology e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone and antihistamine medications such as Claritine;
Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis and systemic lupus erythematosis;
Epilepsy or history of migraines exacerbated by flashing, strobe-like lights;
Eye surgery within 6 months immediately prior to enrolment for this study;
Rigid or soft contact lens wearer, including orthokeratology in the last 30 days;
Previous corneal refractive surgery;
Pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Tan-Showyin, PhD
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry and Vision Science
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Any data included in reports, publications or presented at meetings will be provided in the form of group responses or study identity numbers, such that the participants cannot be identified.
Learn more about this trial
The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye
We'll reach out to this number within 24 hrs