The Effect of a Novel Blueberry Supplement on Dry Eye Disease

Last updated: January 18, 2023
Sponsor: SightSage Foods and Nutrition Inc.
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Dry Eye Disease

Eyelid Inflammation

Treatment

N/A

Clinical Study ID

NCT05027087
43221
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 bearstwice daily for 4 weeks;
  5. As per TFOS DEWS II13, has dry eye symptoms as determined by an OSDI score ≥ 13 ORDEQ-5 ≥ 6, and at least one of the following:
  6. Tear film osmolarity ≥ 308 mOsm/L or interocular difference > 8 mOsm/L
  7. Non-invasive tear film break-up time of <10 seconds in at least one eye
  8. More than 5 spots of corneal staining OR > 9 conjunctiva spots OR lid marginstaining (≥ 2mm length & ≥ 25% width) in at least one eye.

Exclusion

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 oneof the following:
  4. Corneal staining grade ≥ 3 (Oxford scale)
  5. Non-invasive tear film break-up time of ≤ 3 seconds in at least one eye;
  6. Has any known active* ocular disease and/or infection;
  7. Has a systemic condition that in the opinion of the investigator may affect a studyoutcome variable;
  8. Is using any systemic or topical medications (including topical corticosteroids/NSAIDs or glaucoma medications) that in the opinion of the investigator may affect astudy outcome variable;
  9. Is currently taking, or has taken, any supplements containing anti-oxidants in thelast three months;
  10. Has started taking omega-3 supplements within the last 3 months or intend to startthem during the study;
  11. Has a known sensitivity or an allergy to ingredients of the gummy bears;
  12. Has been diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency;
  13. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  14. Is pregnant, lactating or planning a pregnancy at the time of enrolment (byself-report);
  15. Has undergone refractive error surgery or intraocular surgery;
  16. Is a member of CORE directly involved in the study;
  17. 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 orinflammation which requires therapeutic treatment. Mild (i.e. not consideredclinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction,papillae), corneal and conjunctival staining and mild dry eye are not consideredactive ocular disease. Neovascularization and corneal scars are the result ofprevious hypoxia, infection or inflammation and are therefore not active.

Study Design

Total Participants: 68
Study Start date:
September 09, 2021
Estimated Completion Date:
January 11, 2023

Connect with a study center

  • Centre for Ocular Research & Education

    Waterloo, Ontario N2L 3G1
    Canada

    Site Not Available

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