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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2018-06-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Oral supplement containing omega-3 and omega-6

Intervention Type DIETARY_SUPPLEMENT

An oral supplement containing omega-3 and omega-6

Placebo

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

Group Type PLACEBO_COMPARATOR

Oral supplement containing coconut and olive oil

Intervention Type DIETARY_SUPPLEMENT

An oral supplement containing coconut oil and olive oil

Interventions

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Oral supplement containing omega-3 and omega-6

An oral supplement containing omega-3 and omega-6

Intervention Type DIETARY_SUPPLEMENT

Oral supplement containing coconut and olive oil

An oral supplement containing coconut oil and olive oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes