Bilberry-containing Capsules for Dry Eye Mitigation

NCT05737108 | Completed DMC

• 1 other identifier: 111-73
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

bilberry; anthocyanin; dry eye; eye sore; eye strain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change From Baseline of Tear Contents at Day 31

  on baseline and day31

• Change From Baseline of Ocular Surface Impression Cytology at Day 31

  on baseline and day31

• Change From Baseline of Ocular Surface Disease Index Score at Day 31

  on baseline and day31

• Change From Baseline of Intraocular Pressure at Day 31

  on baseline and day31

Study Arms (2)

Group A-test samples

EXPERIMENTAL

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; Dietary Supplement: Placebo(starch)

Group A-placebo

PLACEBO COMPARATOR

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)

Interventions

Bilberry capsule product DIETARY_SUPPLEMENT

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.

Group A-placebo; Group A-test samples

Placebo(starch) DIETARY_SUPPLEMENT

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

Group A-placebo; Group A-test samples

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chung Shan Medical University: lead
• Glory Kingdom Corporation: collaborator

Study Sites (1)

Jen-Ai Hospital

Taichung, 412, Taiwan

Location

Related Publications (9)

• Masmali AM, Purslow C, Murphy PJ. The tear ferning test: a simple clinical technique to evaluate the ocular tear film. Clin Exp Optom. 2014 Sep;97(5):399-406. doi: 10.1111/cxo.12160.

  PMID: 25138744 BACKGROUND

• 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.

  PMID: 17508116 BACKGROUND

• Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.

  PMID: 6712760 BACKGROUND

• 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.

  PMID: 1203224 BACKGROUND

• 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.

  PMID: 25050925 BACKGROUND

• 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.

  PMID: 10235562 BACKGROUND

• Schrader S, Mircheff AK, Geerling G. Animal models of dry eye. Dev Ophthalmol. 2008;41:298-312. doi: 10.1159/000131097.

  PMID: 18453777 BACKGROUND

• 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.

  PMID: 25923485 BACKGROUND

• 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.

  PMID: 32106548 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Asthenopia

Interventions

Vaccinium myrtillus extract; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• David Pei-Cheng Lin, PhD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Only investigators and outcomes assessors have knowledge on whether the samples given are tests or placebo.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: February 21, 2023
• Study Start: August 24, 2022
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 18, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)