Bilberry-containing Capsules for Dry Eye Mitigation

Study Overview
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Brief Summary
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This study investigates whether the oral intake of a bilberry capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 4 bilberry capsules per day for 30 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, and tear compositions. After the 30 days are completed, the participants will be assessed again for the same parameters.

Detailed Description
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This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to group A or group B, and asked to orally intake 4 capsules of either bilberry product or placebo per day.The group A will have bilberry product for 30 days, have a 20-day washout period, and then have placebo for another 30 days. The group B will have placebo for 30 days, have a 20-day washout period, and then have bilberry product for another 30 days. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear composition (Na+, K+, Cl- ions), tear osmolarity, ocular surface impression cytology, and ocular surface disease index (OSDI). The assessments are conducted immediately before the first 30-day and immediately after the second 30-day oral intake period. The parameters are used to compare and evaluate whether the bilberry product can relieve dry eye symptoms.

Official Title
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A Clinical Trial on the Efficacy of Bilberry-containing Capsules for Dry Eye Mitigation

Conditions
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Dry Eye

Intervention / Treatment
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* Dietary Supplement: Bilberry capsule product
* Dietary Supplement: Placebo(starch)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 20 and 65 years with Schirmer's test results between 5 - 10 mm or Tear Film Break Up Time less than 10 seconds Ocular Surface Disease Index more than 25 Exclusion Criteria: evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy. diabetes hypertension or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Intervention with oral intakes of either test samples or placebo for 30 days, followed by a 20-day period of washout, and then crossover for another 30 days of either test samples or placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A-test samples<br>This group will be given test bilberry capsule for 30 days and then have a washout period for 20 days. | Dietary Supplement: Bilberry capsule product<br>* A specific bilberry capsule product, containing bilberry dried extracts at 23.2 mg and bilberry powder at 3.2 mg will be given to participants for oral intake for 30 days. 30 days of Bilberry capsule product or placebo with crossover to the other.<br>Dietary Supplement: Placebo(starch)<br>* 30 days of placebo or Bilberry capsule product with crossover to the other.<br>|
| Placebo Comparator: Group A-placebo<br>This group will be given placebo for 30 days and then have a washout period for 20 days. | Dietary Supplement: Bilberry capsule product<br>* A specific bilberry capsule product, containing bilberry dried extracts at 23.2 mg and bilberry powder at 3.2 mg will be given to participants for oral intake for 30 days. 30 days of Bilberry capsule product or placebo with crossover to the other.<br>Dietary Supplement: Placebo(starch)<br>* 30 days of placebo or Bilberry capsule product with crossover to the other.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of Schirmer's Test Value at Day 31 | To assess tear secretion volume. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Lower measurement indicates presence of dry eye disease. | on baseline and day31 | 
| Change From Baseline of Tear Film Breakup Time at Day 31 | Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Tear Break-Up Time, the lower the tear film stability. Less than 10 seconds = dry eye disease; lower score indicates worse disease. | on baseline and day31 | 
| Change From Baseline of Ocular Surface Index at Day 31 | To assess the health status with Fluorescein stain. Scale ranges from 0 to 3, where grade 0 = None, 3 = Severe | on baseline and day31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of Tear Contents at Day 31 | Determination of changes in osmolality and ion content for test groups of sample or placebo. | on baseline and day31 | 
| Change From Baseline of Ocular Surface Impression Cytology at Day 31 | To assess the status of conjunctival goblet cells and epithelium. | on baseline and day31 | 
| Change From Baseline of Ocular Surface Disease Index Score at Day 31 | A questionnaire to assess the health status on ocular surface, with higher scores indicating greater disability. | on baseline and day31 | 
| Change From Baseline of Intraocular Pressure at Day 31 | To determine the effects of intervention on intraocular pressure. | on baseline and day31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bilberry, anthocyanin, dry eye, eye sore, eye strain