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The Effect of a Novel Blueberry Supplement on Dry Eye Disease (PLUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05027087
Recruitment Status : Completed
First Posted : August 30, 2021
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
SightSage Foods and Nutrition Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Dietary Supplement: Blueberry gummy Dietary Supplement: Placebo gummy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of a Novel Blueberry Supplement on Dry Eye Disease (PLUM)
Actual Study Start Date : September 9, 2021
Actual Primary Completion Date : January 11, 2023
Actual Study Completion Date : January 11, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Participants receive the blueberry gummy supplement
Dietary Supplement: Blueberry gummy
Gummy bear containing blueberry powder

Placebo Comparator: Placebo
Participant receive the placebo gummy supplement
Dietary Supplement: Placebo gummy
Gummy bear with no active ingredients




Primary Outcome Measures :
  1. Change in ODSI score from Baseline [ Time Frame: 4 weeks ]
    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.

  2. Change in Non-Invasive Tear Break-Up Time (NITBUT) from Baseline [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  1. Is at least 18 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Is willing and anticipates to be able to comply with the daily intake of 3 gummy bears twice daily for 4 weeks;
  5. 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:

    1. Tear film osmolarity ≥ 308 mOsm/L or interocular difference > 8 mOsm/L
    2. Non-invasive tear film break-up time of <10 seconds in at least one eye
    3. More than 5 spots of corneal staining OR > 9 conjunctiva spots OR lid margin staining (≥ 2mm length & ≥ 25% width) in at least one eye.

Exclusion Criteria:

A person will be excluded from the study if he/she:

  1. Is participating in any concurrent clinical or research study;
  2. Currently wears, or has worn contact lenses in the past 3 months;
  3. Has symptoms/ signs of severe dry eye, defined by an OSDI score ≥ 33 and at least one of the following:

    1. Corneal staining grade ≥ 3 (Oxford scale)
    2. Non-invasive tear film break-up time of ≤ 3 seconds in at least one eye;
  4. Has any known active* ocular disease and/or infection;
  5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  6. 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;
  7. Is currently taking, or has taken, any supplements containing anti-oxidants in the last three months;
  8. Has started taking omega-3 supplements within the last 3 months or intend to start them during the study;
  9. Has a known sensitivity or an allergy to ingredients of the gummy bears;
  10. Has been diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency;
  11. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  12. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
  13. Has undergone refractive error surgery or intraocular surgery;
  14. Is a member of CORE directly involved in the study;
  15. Has taken part in another (pharmaceutical) research study within the last 30 days.

    • For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

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): NCT05027087


Locations
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Canada, Ontario
Centre for Ocular Research & Education
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
SightSage Foods and Nutrition Inc.
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Responsible Party: SightSage Foods and Nutrition Inc.
ClinicalTrials.gov Identifier: NCT05027087    
Other Study ID Numbers: 43221
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases