Blueberry gummy for Dry Eyes

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Centre for Ocular Research & Education, Waterloo, Canada
Dry Eyes+3 More
Blueberry gummy - DietarySupplement
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a supplement with blueberry powder can improve dry eye signs and symptoms.

See full description

Eligible Conditions

  • Dry Eyes

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Blueberry gummy will improve 2 primary outcomes in patients with Dry Eyes. Measurement will happen over the course of 4 weeks.

4 weeks
Change in Non-Invasive Tear Break-Up Time (NITBUT) from Baseline
Change in ODSI score from Baseline

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Treatment
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Blueberry Gummy is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Treatment
DietarySupplement
Participants receive the blueberry gummy supplement
Placebo
DietarySupplement
Participant receive the placebo gummy supplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 weeks for reporting.

Closest Location

Centre for Ocular Research & Education - Waterloo, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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;
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.

Patient Q&A Section

What is dry eye?

"Dry eye syndrome is a condition affecting the eyes that can cause pain, redness, and irritation. The main cause is reduced production of tears. A warm bath may help with symptoms of dry eye. A condition which results in reduced production of tears, such as aging, can also lead to dry eye. If symptoms do not improve after treatment, a more serious condition known as keratoconjunctivitis sicca, also known as dry eye disease may be present. The underlying pathogenic process may be a dryness problem in the tear film itself. The tear film protects and lubricates the cornea and helps take away debris and mucin which makes the eye smooth and keeps it lubricated." - Anonymous Online Contributor

Unverified Answer

What are common treatments for dry eye?

"Ophthalmic solutions (prescription or over-the-counter) are often indicated in cases of dry eye, including treatment that is primarily focused on eliminating the underlying cause of dry eye. The treatment of more serious cases of dry eye requires a team of specialists, including an ophthalmologist, an optometrist, and a physician specializing in treating dry eye diseases. In some cases of dry eye, the underlying cause may not be the focus of treatment, and therapy aimed primarily at the tear fluid is sometimes warranted." - Anonymous Online Contributor

Unverified Answer

What causes dry eye?

"Symptoms and signs such as redness, burning and itchiness, blurred vision, and eye discomfort due to a dry eye problem may be caused by a number of conditions and situations. Dry and evaporated types of tears are the most common. However, dry and evaporated tears caused by a range of disease, conditions, medication effects and allergy may also occur." - Anonymous Online Contributor

Unverified Answer

How many people get dry eye a year in the United States?

"One out of 5 men and 2 out of 3 women over the age of 15 years are affected by dry eye. It is estimated that 20.5 million adults in the United States may have dry eye. The American Academy of Ophthalmology estimates that 1 in 9 Americans will have dry eye when they reaches an age of 65." - Anonymous Online Contributor

Unverified Answer

Can dry eye be cured?

"The data suggest that even in patients with refractory ODE refractive surgery may be beneficial in some cases, while in others a long-term course of topical antifungal therapy has to be expected. This is particularly true when using autologous serum as a treatment." - Anonymous Online Contributor

Unverified Answer

What are the signs of dry eye?

"The symptoms of dry eye include a sensation of thirstiness, irritation to the eye, and excess tearing. The symptoms worsen with time and may last a number of days.\n" - Anonymous Online Contributor

Unverified Answer

What is the primary cause of dry eye?

"In a recent study, findings can provide the following answers: (1) the primary cause of dry eye is tear evaporation in the tear film; (2) this may be due to a reduced tear film of normal size." - Anonymous Online Contributor

Unverified Answer

Has blueberry gummy proven to be more effective than a placebo?

"When evaluating whether a noninvasive intervention is effective on outcomes such as dry eye symptoms, it is best to use an objective measure as a surrogate endpoint, or outcome, of the intervention effect. Using B." - Anonymous Online Contributor

Unverified Answer

Is blueberry gummy typically used in combination with any other treatments?

"Results from a recent paper suggested that there was no significant difference in efficacy between blueberry gummy with other treatments compared to blueberry gummy alone. However, blueberry gummy alone showed the most rapid disappearance of symptom score within 24 hours after treatment." - Anonymous Online Contributor

Unverified Answer

What does blueberry gummy usually treat?

"The clinical responses obtained using blueberry gummy (Blue Hymelo) were clinically statistically significant better than placebo, but insignificant from one another in all parameters evaluated. There was no effect in the recovery of corneal goblet cell and tear film function. It is concluded from this study that a single ingestion of Blue Hymelo is clinically ineffective at treating dry or damp eyes. More research is needed to ascertain whether a single use of Blue Hymelo can improve the ocular mucosal defenses, especially with regard to epithelial function. Also, prolonged usage of Blue Hymelo may be more effective than a single use." - Anonymous Online Contributor

Unverified Answer

Does dry eye run in families?

"The prevalence of dry eye in the studied families was higher than expected. Although dry eye seems to be genetically determined to a certain extent, environmental factors such as smoking and dust exposure may contribute to its development and thus to the development of this condition." - Anonymous Online Contributor

Unverified Answer

Does blueberry gummy improve quality of life for those with dry eye?

"Oral administration of blueberry gummies improved the quality of life and satisfaction with eye symptom relief of patients with dry eye as well as subjective improvements in their eye symptoms." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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