NCT05027087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

September 9, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

August 25, 2021

Last Update Submit

January 18, 2023

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Treatment

EXPERIMENTAL

Participants receive the blueberry gummy supplement

Dietary Supplement: Blueberry gummy

Placebo

PLACEBO COMPARATOR

Participant receive the placebo gummy supplement

Dietary Supplement: Placebo gummy

Interventions

Blueberry gummyDIETARY_SUPPLEMENT

Gummy bear containing blueberry powder

Treatment
Placebo gummyDIETARY_SUPPLEMENT

Gummy bear with no active ingredients

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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:
  • Corneal staining grade ≥ 3 (Oxford scale)
  • Non-invasive tear film break-up time of ≤ 3 seconds in at least one eye;
  • 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);
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 30, 2021

Study Start

September 9, 2021

Primary Completion

January 11, 2023

Study Completion

January 11, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)