Bilberry-containing Capsules for Dry Eye Mitigation

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737108
• Other study ID #: 111-73
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2023
• Source: Chung Shan Medical University
• Contact: David Pei-Cheng Lin, PhD
• Phone: 886-910-371286
• Email: pcl[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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.
• Placebo(starch)
30 days of placebo or Bilberry capsule product with crossover to the other.

Locations

Country	Name	City	State
Taiwan	Jen-Ai Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	Glory Kingdom Corporation

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change From Baseline of Tear Contents at Day 31	Determination of changes in osmolality and ion content for test groups of sample or placebo.	on baseline and day31
Secondary	Change From Baseline of Ocular Surface Impression Cytology at Day 31	To assess the status of conjunctival goblet cells and epithelium.	on baseline and day31
Secondary	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.	on baseline and day31
Secondary	Change From Baseline of Intraocular Pressure at Day 31	To determine the effects of intervention on intraocular pressure.	on baseline and day31