Dry EyeNCT03141931

The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye

A study testing Supplement in people with Dry Eye, run by The University of New South Wales at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Dry Eye
What is being tested?: Supplement
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 119 participants
Where: 1 siteAustralia
Study dates: 21 Aug 2017to 19 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

School of Optometry and Vision Science
Sydney, New South Wales, 2052

Other trials in Australia

About this study

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

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.

Read the 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.

Conditions: Dry Eye
Being tested: Supplement, Placebo
Keywords: Nutraceutical supplement
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.

SupplementDietary supplement
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
PlaceboDietary supplement
polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)

Study groups in NCT03141931
Study group	Role	What they receive
Supplement	Experimental	Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids Receives: Dietary Supplement: Supplement
Placebo	Placebo comparator	Polyethylene glycol, Oleic acid, Propylene glycol Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months

Secondary outcomes (5)

Non-invasive Tear Film Break-up Time
Measured in seconds using the Oculus Keratograph. Higher value represents better outcome.
Measured: 3 months
Tear Evaporation Rate
Measured in g.m^2.h using the Vapometer
Measured: 3 months
Tear Meniscus Height
Measured in millimeters using the Oculus Keratograph 5M
Measured: 3 months
Tear Volume
Measured in millimeters using phenol red thread tests
Measured: 3 months
Tear Film Lipid Layer Thickness
Measured in nanometers using the LipiView ocular surface interferometer
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 201719 Oct 2018

First posted5 May 2017
Study start21 Aug 2017
Primary completion19 Oct 2018
Study completion19 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03141931
Sponsor's protocol ID: SOVS2016-045
Status last verified: May 2020
First submitted: 6 Feb 2017
Last updated: 11 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03141931
Acronym / sponsor ID: SOVS2016-045
Conditions: Dry Eye
Keywords: Nutraceutical supplement
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: The University of New South WalesUniversity, hospital or other
Study start: 21 Aug 2017 (actual)
Primary completion: 19 Oct 2018 (actual)
Study completion: 19 Oct 2018 (actual)
First posted: 5 May 2017 (actual)
Results: Posted 11 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Supplement	Experimental	Dietary Supplement: SupplementCombination of flaxseed oil, borage oil and fish oil omega-3 fatty acids
Placebo	Placebo comparator	Dietary Supplement: PlaceboPolyethylene glycol, Oleic acid, Propylene glycol

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (12 listed)

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:
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;

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
SupplementConcentrated 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	Dietary supplement	Supplement
Placebopolyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)	Dietary supplement	Placebo

Primary outcome

Subjective Ocular Symptoms
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
Measured using the Dry Eye Questionnaire 5. Dry eye questionnaire 5 score ranges from 0 to 22. Lower score represents better outcome.

5 secondary outcomes

Non-invasive Tear Film Break-up Time
Time frame: 3 months
Tear Evaporation Rate
Time frame: 3 months
Tear Meniscus Height
Time frame: 3 months
Tear Volume
Time frame: 3 months
Tear Film Lipid Layer Thickness
Time frame: 3 months

Results and safety

Results posted to the registry on 11 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lacritec	61	49
Placebo	58	52

Primary outcome: Subjective Ocular Symptoms

Time frame: 3 months. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Lacritec n = 61	Placebo n = 58
Value	27.42 (11.18 to 43.66)	27.43 (11.8 to 43.48)

Population analysed: All participant received at-least one dose of treatment.

Primary outcome: Subjective Ocular Comfort

Time frame: 3 months. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Lacritec n = 61	Placebo n = 58
Value	35.61 (27.08 to 44.14)	35.66 (27.11 to 44.21)

Population analysed: All participants received at least one dose of treatment.

Primary outcome: Subjective Ocular Dryness

Time frame: 3 months. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Lacritec n = 61	Placebo n = 58
Value	9.75 (5.81 to 13.69)	9.78 (5.89 to 13.67)

Population analysed: All participants received at least one dose of treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lacritec	0 of 61 (0%)	13 of 61 (21.3%)	0 of 61
Placebo	0 of 58 (0%)	15 of 58 (25.9%)	0 of 58

Limitations and caveats (from the sponsor): To manufacture the placebo soft gel capsule, inclusion of oleic acid in the formulation was required, which could have an influence on the placebo arm of the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. 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.

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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.

Jacqueline Tan-Showyin, PhD principal investigator

University of New South Wales

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Supplement in people with Dry Eye, run by The University of New South Wales at 1 site in Australia.

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 9 inclusion and 12 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 11 Jun 2020. 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 Australia. 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?

Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Subjective Ocular Symptoms (time frame: 3 months). The study lists 3 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 NCT03141931.

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 11 Jun 2020.