Bilberry-containing Capsules for Dry Eye Mitigation

Chung Shan Medical University

Status: Completed

Conditions: Dry Eye

Treatments: Dietary Supplement: Bilberry capsule product; Dietary Supplement: Placebo(starch)

Study type: Interventional

Funder types: Other

Identifiers

NCT05737108

111-73

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Group A-test samples

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo(starch)

Dietary Supplement: Bilberry capsule product

Group A-placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo(starch)

Dietary Supplement: Bilberry capsule product