An interventional study of Oral supplement containing omega-3 and omega-6 and Oral supplement containing coconut and olive oil in Dry Eye, sponsored by Nature's Way Canada. Completed at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Nature's Way Canada · Not applicable, Interventional, and Treatment
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.
Exhibit moderate ocular dryness symptoms, defined as:
Exclusion Criteria:
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
Subjects will receive an oral supplement containing coconut oil and light olive oil.
Dietary Supplement: Oral supplement containing coconut and olive oil
An oral supplement containing omega-3 and omega-6
An oral supplement containing coconut oil and olive oil
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 3 months
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Time frame: At screening
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Time frame: At 1 month
Objective non-invasive tear film stability (NIKBUT)
Time taken for tear film breakup as measured objectively in seconds.
Time frame: At 3 months
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.
Time frame: At screening
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.
Time frame: At 1 month
Non-invasive tear break up time (NITBUT)
Time taken for tear film breakup as measured by a study investigator in seconds.
Time frame: At 3 months
Change in Bulbar hyperemia after 3 months
The redness of the bulbar conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps).
Time frame: At screening, 1 month and 3 months
Change in Limbal hyperemia after 3 months
The redness of the limbal conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps).
Time frame: At screening, 1 month and 3 months
Change in Tear meniscus height after 3 months
Measurement of tear meniscus height in mm.
Time frame: At screening, 1 month and 3 months
Change in Meiboscore (Arita's scale) after 3 months
Graded on 0-3 scale. Grade 0: no dropout, Grade 1: \< 1/3 total area dropout, Grade 2: 1/3 to 2/3 total area dropout, Grade 3: \> 2/3 total area dropout
Time frame: At screening, 1 month and 3 months
Change in Visual acuity after 3 months
High contrast logMAR VA with computerized charts in high illumination
Time frame: At screening, 1 month and 3 months
Change in Tear osmolarity after 3 months
Measure of the osmolarity of collected tears.
Time frame: At screening and 3 months
Change in Omega-3 index after 3 months
Amount of EPA and DHA in erythrocytes
Time frame: At screening and 3 months
Plan to share: No
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