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The objective of this study is to evaluate the efficacy of a novel oral supplement (gummy bear) with blueberry powder on reducing dry eye signs and symptoms and assess its safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants receive the blueberry gummy supplement |
|
| Placebo | Placebo Comparator | Participant receive the placebo gummy supplement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry gummy | Dietary Supplement | Gummy bear containing blueberry powder |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ODSI score from Baseline | The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Change between the score at baseline and the score at 4 weeks is reported. | 4 weeks |
| Change in Non-Invasive Tear Break-Up Time (NITBUT) from Baseline | The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. The change in this time (measured in seconds) between baseline and 4 weeks is reported. | 4 weeks |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Is at least 18 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is willing and anticipates to be able to comply with the daily intake of 3 gummy bears twice daily for 4 weeks;
As per TFOS DEWS II13, has dry eye symptoms as determined by an OSDI score ≥ 13 OR DEQ-5 ≥ 6, and at least one of the following:
Exclusion Criteria:
A person will be excluded from the study if he/she:
Is participating in any concurrent clinical or research study;
Currently wears, or has worn contact lenses in the past 3 months;
Has symptoms/ signs of severe dry eye, defined by an OSDI score ≥ 33 and at least one of the following:
Has any known active* ocular disease and/or infection;
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 taken, any supplements containing anti-oxidants in the last three months;
Has started taking omega-3 supplements within the last 3 months or intend to start them during the study;
Has a known sensitivity or an allergy to ingredients of the gummy bears;
Has been diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency;
Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
Has undergone refractive error surgery or intraocular surgery;
Is a member of CORE directly involved in the study;
Has taken part in another (pharmaceutical) research study within the last 30 days.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo gummy |
| Dietary Supplement |
Gummy bear with no active ingredients |
|