Trial | NCT03265327  Report issue

Title

Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms
The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    63
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.
Study Started
Aug 16
2017
Primary Completion
Jun 27
2018
Study Completion
Jun 27
2018
Last Update
Apr 29
2021

Dietary Supplement Oral supplement containing omega-3 and omega-6 [omega-3 fatty acids (Omacor), omega-6 fatty acids]

An oral supplement containing omega-3 and omega-6

Dietary Supplement Oral supplement containing coconut and olive oil [coconut oil, olive]

An oral supplement containing coconut oil and olive oil

Treatment Experimental

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

Placebo Placebo Comparator

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

Criteria 

Inclusion Criteria:

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.

Exclusion Criteria:

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;
No Results Posted