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

• ClinicalTrials.gov Identifier: NCT05027087
• Recruitment Status: Completed
• First Posted: August 30, 2021
• Last Update Posted: January 20, 2023
• Sponsor: SightSage Foods and Nutrition Inc.
• Information provided by (Responsible Party): SightSage Foods and Nutrition Inc.

Tracking Information

• First Submitted Date: August 25, 2021
• First Posted Date: August 30, 2021
• Last Update Posted Date: January 20, 2023
• Actual Study Start Date: September 9, 2021
• Actual Primary Completion Date: January 11, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 25, 2021)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of a Novel Blueberry Supplement on Dry Eye Disease
• Official Title: The Effect of a Novel Blueberry Supplement on Dry Eye Disease (PLUM)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Dry Eye

Intervention

• Dietary Supplement: Blueberry gummy
  Gummy bear containing blueberry powder
• Dietary Supplement: Placebo gummy
  Gummy bear with no active ingredients

Study Arms

• Experimental: Treatment
  Participants receive the blueberry gummy supplement
  Intervention: Dietary Supplement: Blueberry gummy
• Placebo Comparator: Placebo
  Participant receive the placebo gummy supplement
  Intervention: Dietary Supplement: Placebo gummy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 18, 2023): 68
• Original Estimated Enrollment (submitted: August 25, 2021): 60
• Actual Study Completion Date: January 11, 2023
• Actual Primary Completion Date: January 11, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT05027087
• Other Study ID Numbers: 43221
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: SightSage Foods and Nutrition Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: SightSage Foods and Nutrition Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: SightSage Foods and Nutrition Inc.
• Verification Date: January 2023