Bilberry-containing Capsules for Dry Eye Mitigation

Not Applicable

Completed

• Conditions: Dry Eye
• Interventions: Dietary Supplement: Bilberry capsule product; Dietary Supplement: Placebo(starch)

• Registration Number: NCT05737108
• Lead Sponsor: Chung Shan Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-08-24
• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-21
• Status Verified: 2023-05
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A-test samples	Placebo(starch)	This group will be given test bilberry capsule for 30 days and then have a washout period for 20 days.
Group A-test samples	Bilberry capsule product	This group will be given test bilberry capsule for 30 days and then have a washout period for 20 days.
Group A-placebo	Bilberry capsule product	This group will be given placebo for 30 days and then have a washout period for 20 days.
Group A-placebo	Placebo(starch)	This group will be given placebo for 30 days and then have a washout period for 20 days.

Primary Outcome Measures

Name	Time	Method
Change From Baseline of Tear Film Breakup Time at Day 31	on baseline and day31	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.
Change From Baseline of Ocular Surface Index at Day 31	on baseline and day31	To assess the health status with Fluorescein stain. Scale ranges from 0 to 3, where grade 0 = None, 3 = Severe
Change From Baseline of Schirmer's Test Value at Day 31	on baseline and day31	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jen-Ai Hospital; 🇨🇳 Taichung, Taiwan