Dry Eye Symptom Mitigation by Oral Intake of Probiotics

Last updated: June 14, 2023
Sponsor: Chung Shan Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dry Eye Disease

Sjogren's Syndrome

Eyelid Inflammation

Treatment

Probiotics

Placebo

Clinical Study ID

NCT05906381
202300014B0
  • Ages 20-65
  • All Genders

Study Summary

This study investigates whether the oral intake of a probiotics 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 1 probiotics capsule per day for 35 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, tear osmolarity and serum biochemical test. After the 35 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 less than 10 mm or 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, terminal illindividuals)

Study Design

Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Probiotics
Phase:
Study Start date:
May 13, 2023
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 control group or treatment group, and asked to orally intake 1 capsule of either placebo or probiotics per day. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear osmolarity, ocular surface impression cytology, ocular surface disease index (OSDI) and serum biochemical tests for quantification of hyaluronic acid, sialic acid, glutathione contents.The assessments are conducted at day1 for baseline and after the 35-day oral intake. The parameters are used to compare and evaluate whether the probiotics can relieve dry eye symptoms.

Connect with a study center

  • Jen-Ai Hospital

    Taichung, 412
    Taiwan

    Active - Recruiting

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