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| Name | Class |
|---|---|
| Centre for Contact Lens Research | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral supplement containing omega-3 and omega-6 | Dietary Supplement | An oral supplement containing omega-3 and omega-6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At screening, 1 month and 3 months |
| Change in Limbal hyperemia after 3 months |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34882608 | Derived | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Oral supplement containing coconut and olive oil | Dietary Supplement | An oral supplement containing coconut oil and olive oil |
|
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 |
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). |
| At screening, 1 month and 3 months |
| Change in Tear meniscus height after 3 months | Measurement of tear meniscus height in mm. | 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 | At screening, 1 month and 3 months |
| Change in Visual acuity after 3 months | High contrast logMAR VA with computerized charts in high illumination | At screening, 1 month and 3 months |
| Change in Tear osmolarity after 3 months | Measure of the osmolarity of collected tears. | At screening and 3 months |
| Change in Omega-3 index after 3 months | Amount of EPA and DHA in erythrocytes | At screening and 3 months |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |