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

NCT03265327 | Completed

• 1 other identifier: 22309
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At 3 months

• Objective non-invasive tear film stability (NIKBUT)

  Time taken for tear film breakup as measured objectively in seconds.

  At screening

• Objective non-invasive tear film stability (NIKBUT)

  Time taken for tear film breakup as measured objectively in seconds.

  At 1 month

• Objective non-invasive tear film stability (NIKBUT)

  Time taken for tear film breakup as measured objectively in seconds.

  At 3 months

• Non-invasive tear break up time (NITBUT)

  Time taken for tear film breakup as measured by a study investigator in seconds.

  At screening

• Non-invasive tear break up time (NITBUT)

  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 taken for tear film breakup as measured by a study investigator in seconds.

  At 3 months

Secondary Outcomes (7)

• Change in Bulbar hyperemia after 3 months

  At screening, 1 month and 3 months

• Change in Limbal hyperemia after 3 months

  At screening, 1 month and 3 months

• Change in Tear meniscus height after 3 months

  At screening, 1 month and 3 months

• Change in Meiboscore (Arita's scale) after 3 months

  At screening, 1 month and 3 months

• Change in Visual acuity after 3 months

  At screening, 1 month and 3 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Oral supplement containing coconut and olive oil

Interventions

Oral supplement containing omega-3 and omega-6 DIETARY_SUPPLEMENT

An oral supplement containing omega-3 and omega-6

Treatment

Oral supplement containing coconut and olive oil DIETARY_SUPPLEMENT

An oral supplement containing coconut oil and olive oil

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Nature's Way Canada: lead
• Centre for Contact Lens Research: collaborator

Study Sites (1)

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

Related Publications (1)

• 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.

  PMID: 34882608 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 29, 2017
• Study Start: August 16, 2017
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)