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Bilberry-containing Capsules for Dry Eye Mitigation

Primary Purpose

Dry Eye

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bilberry capsule product
Placebo(starch)
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring bilberry, anthocyanin, dry eye, eye sore, eye strain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Jen-Ai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A-test samples

Group A-placebo

Arm Description

This group will be given test bilberry capsule for 30 days and then have a washout period for 20 days.

This group will be given placebo for 30 days and then have a washout period for 20 days.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Change From Baseline of Tear Contents at Day 31
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
To assess the status of conjunctival goblet cells and epithelium.
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.
Change From Baseline of Intraocular Pressure at Day 31
To determine the effects of intervention on intraocular pressure.

Full Information

First Posted
November 18, 2022
Last Updated
May 19, 2023
Sponsor
Chung Shan Medical University
Collaborators
Glory Kingdom Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05737108
Brief Title
Bilberry-containing Capsules for Dry Eye Mitigation
Official Title
A Clinical Trial on the Efficacy of Bilberry-containing Capsules for Dry Eye Mitigation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chung Shan Medical University
Collaborators
Glory Kingdom Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
bilberry, anthocyanin, dry eye, eye sore, eye strain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare Provider
Masking Description
Only investigators and outcomes assessors have knowledge on whether the samples given are tests or placebo.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A-test samples
Arm Type
Experimental
Arm Description
This group will be given test bilberry capsule for 30 days and then have a washout period for 20 days.
Arm Title
Group A-placebo
Arm Type
Placebo Comparator
Arm Description
This group will be given placebo for 30 days and then have a washout period for 20 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bilberry capsule product
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo(starch)
Intervention Description
30 days of placebo or Bilberry capsule product with crossover to the other.
Primary Outcome Measure Information:
Title
Change From Baseline of Schirmer's Test Value at Day 31
Description
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.
Time Frame
on baseline and day31
Title
Change From Baseline of Tear Film Breakup Time at Day 31
Description
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.
Time Frame
on baseline and day31
Title
Change From Baseline of Ocular Surface Index at Day 31
Description
To assess the health status with Fluorescein stain. Scale ranges from 0 to 3, where grade 0 = None, 3 = Severe
Time Frame
on baseline and day31
Secondary Outcome Measure Information:
Title
Change From Baseline of Tear Contents at Day 31
Description
Determination of changes in osmolality and ion content for test groups of sample or placebo.
Time Frame
on baseline and day31
Title
Change From Baseline of Ocular Surface Impression Cytology at Day 31
Description
To assess the status of conjunctival goblet cells and epithelium.
Time Frame
on baseline and day31
Title
Change From Baseline of Ocular Surface Disease Index Score at Day 31
Description
A questionnaire to assess the health status on ocular surface, with higher scores indicating greater disability.
Time Frame
on baseline and day31
Title
Change From Baseline of Intraocular Pressure at Day 31
Description
To determine the effects of intervention on intraocular pressure.
Time Frame
on baseline and day31

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Pei-Cheng Lin, PhD
Phone
886-910-371286
Email
pcl@csmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chieh-Hung Yen, MD
Phone
886-4-24819900
Email
chiehhungyen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pei-Cheng Lin, PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jen-Ai Hospital
City
Taichung
ZIP/Postal Code
412
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pei-Cheng Lin, PhD
Phone
886-910-371286
Email
pcl@csmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chien-Hung Yen, MD
Phone
886-4-24819900
Email
chienhungyen@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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25138744
Citation
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Results Reference
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PubMed Identifier
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Citation
The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
Results Reference
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PubMed Identifier
6712760
Citation
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Results Reference
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PubMed Identifier
1203224
Citation
Wilson WS, Duncan AJ, Jay JL. Effect of benzalkonium chloride on the stability of the precorneal tear film in rabbit and man. Br J Ophthalmol. 1975 Nov;59(11):667-9. doi: 10.1136/bjo.59.11.667.
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PubMed Identifier
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Citation
Brito-Zeron P, Ramos-Casals M; EULAR-SS task force group. Advances in the understanding and treatment of systemic complications in Sjogren's syndrome. Curr Opin Rheumatol. 2014 Sep;26(5):520-7. doi: 10.1097/BOR.0000000000000096.
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Citation
Sullivan DA, Krenzer KL, Sullivan BD, Tolls DB, Toda I, Dana MR. Does androgen insufficiency cause lacrimal gland inflammation and aqueous tear deficiency? Invest Ophthalmol Vis Sci. 1999 May;40(6):1261-5.
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Citation
Schrader S, Mircheff AK, Geerling G. Animal models of dry eye. Dev Ophthalmol. 2008;41:298-312. doi: 10.1159/000131097.
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PubMed Identifier
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Citation
Ozawa Y, Kawashima M, Inoue S, Inagaki E, Suzuki A, Ooe E, Kobayashi S, Tsubota K. Bilberry extract supplementation for preventing eye fatigue in video display terminal workers. J Nutr Health Aging. 2015 May;19(5):548-54. doi: 10.1007/s12603-014-0573-6.
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PubMed Identifier
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Citation
Kosehira M, Machida N, Kitaichi N. A 12-Week-Long Intake of Bilberry Extract (Vaccinium myrtillus L.) Improved Objective Findings of Ciliary Muscle Contraction of the Eye: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Trial. Nutrients. 2020 Feb 25;12(3):600. doi: 10.3390/nu12030600.
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Bilberry-containing Capsules for Dry Eye Mitigation

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