Dry EyePhase 3PLUMNCT05027087
The Effect of a Novel Blueberry Supplement on Dry Eye Disease
A Phase 3 study testing Blueberry gummy in people with Dry Eye, run by SightSage Foods and Nutrition Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Blueberry gummy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2021to 11 Jan 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- 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:
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- 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.
Who cannot join
- 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;
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- 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);
- Has undergone refractive error surgery or intraocular surgery;
- Is a member of CORE directly involved in the study;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dry Eye
- Being tested
- Blueberry gummy, Placebo gummy
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry gummyDietary supplement
Gummy bear containing blueberry powder
Placebo gummyDietary supplement
Gummy bear with no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants receive the blueberry gummy supplement Receives: Dietary Supplement: Blueberry gummy |
| Placebo | Placebo comparator | Participant receive the placebo gummy supplement Receives: Dietary Supplement: Placebo gummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start9 Sep 2021
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- SightSage Foods and Nutrition Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027087
- Sponsor's protocol ID
- 43221
- Acronym
- PLUM
- Status last verified
- Jan 2023
- First submitted
- 25 Aug 2021
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Novel Blueberry Supplement on Dry Eye Disease (PLUM)
- ClinicalTrials.gov ID
- NCT05027087
- Acronym / sponsor ID
- PLUM / 43221
- Conditions
- Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- SightSage Foods and Nutrition Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Blueberry gummyParticipants receive the blueberry gummy supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo gummyParticipant receive the placebo gummy supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (19 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry gummyGummy bear containing blueberry powder | Dietary supplement | Treatment |
| Placebo gummyGummy bear with no active ingredients | Dietary supplement | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blueberry gummy in people with Dry Eye, run by SightSage Foods and Nutrition Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ODSI score from Baseline (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.