Bilberry-containing Capsules for Dry Eye Mitigation

Last updated: February 14, 2025
Sponsor: Chung Shan Medical University
Overall Status: Completed

Phase

N/A

Condition

Sjogren's Syndrome

Eyelid Inflammation

Dry Eye Disease

Treatment

Bilberry capsule product

Placebo(starch)

Clinical Study ID

NCT05737108
111-73
  • Ages 20-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, disabledindividuals such as those at terminal stage of tumorigenesis, blindness, terminalill individuals)

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Bilberry capsule product
Phase:
Study Start date:
August 24, 2022
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Jen-Ai Hospital

    Taichung, 412
    Taiwan

    Site Not Available

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