An interventional study of Bilberry capsule product and Placebo(starch) in Dry Eye, sponsored by Chung Shan Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Treatment
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.
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
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)
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)
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.
30 days of placebo or Bilberry capsule product with crossover to the other.
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.
Time frame: 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.
Time frame: 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
Time frame: on baseline and day31
Change From Baseline of Tear Contents at Day 31
Determination of changes in osmolality and ion content for test groups of sample or placebo.
Time frame: on baseline and day31
Change From Baseline of Ocular Surface Impression Cytology at Day 31
To assess the status of conjunctival goblet cells and epithelium.
Time frame: on baseline and day31
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.
Time frame: on baseline and day31
Change From Baseline of Intraocular Pressure at Day 31
To determine the effects of intervention on intraocular pressure.
Time frame: on baseline and day31
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Chung Shan Medical University