Clinical trial NCT05737108: Bilberry-containing Capsules for Dry Eye Mitigation
Official title: A Clinical Trial on the Efficacy of Bilberry-containing Capsules for Dry Eye Mitigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: bilberry
anthocyanin
dry eye
eye sore
eye strain
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Glory Kingdom Corporation
First posted: 2023-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intervention with oral intakes of either test samples or placebo for 30 days, followed by a 20-day period of washout, and then crossover for another 30 days of either test samples or placebo.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline of Schirmer's Test Value at Day 31
timeFrame: on baseline and day31
measure: Change From Baseline of Tear Film Breakup Time at Day 31
timeFrame: on baseline and day31
measure: Change From Baseline of Ocular Surface Index at Day 31
timeFrame: on baseline and day31
Secondary outcomes:
measure: Change From Baseline of Tear Contents at Day 31
timeFrame: on baseline and day31
measure: Change From Baseline of Ocular Surface Impression Cytology at Day 31
timeFrame: on baseline and day31
measure: Change From Baseline of Ocular Surface Disease Index Score at Day 31
timeFrame: on baseline and day31
measure: Change From Baseline of Intraocular Pressure at Day 31
timeFrame: on baseline and day31
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Jen-Ai Hospital
Study officials:
affiliation: Chung Shan Medical University
name: David Pei-Cheng Lin, PhD
role: PRINCIPAL_INVESTIGATOR
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