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NCT Number: NCT05737108

Bilberry-containing Capsules for Dry Eye Mitigation

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.

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Key information

Conditions

Dry Eye Asthenopia Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jen-Ai Hospital

Taichung, 412, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Placebo(starch)

Dietary Supplement

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

Primary outcomes

  1. Change From Baseline of Schirmer's Test Value at Day 31

    Time frame: on baseline and day31

    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.

  2. Change From Baseline of Tear Film Breakup Time at Day 31

    Time frame: on baseline and day31

    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.

  3. Change From Baseline of Ocular Surface Index at Day 31

    Time frame: on baseline and day31

    To assess the health status with Fluorescein stain. Scale ranges from 0 to 3, where grade 0 = None, 3 = Severe

Secondary outcomes

  1. Change From Baseline of Tear Contents at Day 31

    Time frame: on baseline and day31

    Determination of changes in osmolality and ion content for test groups of sample or placebo.

  2. Change From Baseline of Ocular Surface Impression Cytology at Day 31

    Time frame: on baseline and day31

    To assess the status of conjunctival goblet cells and epithelium.

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

    Time frame: on baseline and day31

    A questionnaire to assess the health status on ocular surface, with higher scores indicating greater disability.

  4. Change From Baseline of Intraocular Pressure at Day 31

    Time frame: on baseline and day31

    To determine the effects of intervention on intraocular pressure.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • Glory Kingdom Corporation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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