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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Dietary supplement: Blueberry gummy; Dietary supplement: Placebo gummy

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Ocular Research & Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: SightSage Foods and Nutrition Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): January 11, 2023
• Study Completion (Actual): January 11, 2023

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 43221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No