Bilberry-containing Capsules for Dry Eye Mitigation

Sponsor

Chung Shan Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05737108

Collaborator

Glory Kingdom Corporation (Other)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Dietary Supplement: Bilberry capsule product Dietary Supplement: Placebo(starch)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Participant, Care Provider)

Masking Description:

Only investigators and outcomes assessors have knowledge on whether the samples given are tests or placebo.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 24, 2022

Anticipated Primary Completion Date :

Jul 23, 2023

Anticipated Study Completion Date :

Jul 23, 2023

Arms and Interventions

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.

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

Dietary Supplement: Placebo(starch)

30 days of placebo or Bilberry capsule product with crossover to the other.

Outcome Measures

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)