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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

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ClinicalTrials.gov Identifier: NCT03141931
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Stiltec Pty Ltd
Australian Government
Information provided by (Responsible Party):
Jacqueline Tan-Showyin, The University of New South Wales

Brief Summary:
The aim of this study is to compare ocular symptoms and signs when Lacritec 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 Lacritec nutraceutical formulation, which is an wholly Australian owned product. 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.

Condition or disease Intervention/treatment Phase
Dry Eye Dietary Supplement: Lacritec Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double masked
Primary Purpose: Treatment
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
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : October 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lacritec
Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids
Dietary Supplement: Lacritec
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

Placebo Comparator: Placebo
Polyethylene glycol, Oleic acid, Propylene glycol
Dietary Supplement: Placebo
polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)




Primary Outcome Measures :
  1. Subjective ocular symptoms [ Time Frame: 3 months ]
    Measured using the Ocular Surface Disease Index questionnaire

  2. Subjective ocular comfort [ Time Frame: 3 months ]
    Measured using the Ocular Comfort Index questionnaire

  3. Subjective ocular dryness [ Time Frame: 3 months ]
    Measured using the Dry Eye Questionnaire 5


Secondary Outcome Measures :
  1. Non-invasive tear film break-up time [ Time Frame: 3 months ]
    Measured in seconds using the Oculus Keratograph 5M

  2. Tear evaporation rate [ Time Frame: 3 months ]
    Measured in g m-2 h using the Vapometer

  3. Tear meniscus height [ Time Frame: 3 months ]
    Measured in millimeters using the Oculus Keratograph 5M

  4. Tear volume [ Time Frame: 3 months ]
    Measured in millimeters using phenol red thread tests

  5. Tear film lipid layer thickness [ Time Frame: 3 months ]
    Measured in nanometers using the LipiView ocular surface interferometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141931


Locations
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Australia, New South Wales
School of Optometry and Vision Science
Sydney, New South Wales, Australia, 2052
Sponsors and Collaborators
The University of New South Wales
Stiltec Pty Ltd
Australian Government
Investigators
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Principal Investigator: Jacqueline Tan-Showyin, PhD University of New South Wales

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Responsible Party: Jacqueline Tan-Showyin, Senior Research Fellow, The University of New South Wales
ClinicalTrials.gov Identifier: NCT03141931     History of Changes
Other Study ID Numbers: SOVS2016-045
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacqueline Tan-Showyin, The University of New South Wales:
Nutraceutical supplement

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Borage oil
Antirheumatic Agents