Bilberry-containing Capsules for Dry Eye Mitigation

February 14, 2025 updated by: Chung Shan Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 412
        • Jen-Ai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A-test samples
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
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.
Dietary supplement: Placebo(starch)
30 days of placebo or Bilberry capsule product with crossover to the other.
Placebo Comparator: Group A-placebo
This group will be given placebo for 30 days and then have a washout period for 20 days.
Dietary supplement: Bilberry capsule product
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.
Dietary supplement: Placebo(starch)
30 days of placebo or Bilberry capsule product with crossover to the other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline of Schirmer's Test Value at Day 31
Time Frame: 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.
on baseline and day31
Change From Baseline of Tear Film Breakup Time at Day 31
Time Frame: 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.
on baseline and day31
Change From Baseline of Ocular Surface Index at Day 31
Time Frame: on baseline and day31
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
Time Frame: on baseline and day31
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
Time Frame: on baseline and day31
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
Time Frame: on baseline and day31
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
Time Frame: on baseline and day31
To determine the effects of intervention on intraocular pressure.
on baseline and day31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Collaborators

Glory Kingdom Corporation

Investigators

  • Principal Investigator: David Pei-Cheng Lin, PhD, Chung Shan Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111-73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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