Clinical trial NCT05906381: Dry Eye Symptom Mitigation by Oral Intake of Probiotics
Official title: A Clinical Trial of Dry Eye Symptom Mitigation by Oral Intake of Probiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Keywords: probiotics
dry eye
eye sore
eye strain
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Nutrarex Biotech Co., Ltd.
First posted: 2023-06-15
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 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 of Schirmer's Test Value from Baseline
timeFrame: on baseline and day36
measure: Change of Tear Film Breakup Time from Baseline
timeFrame: on baseline and day36
measure: Ocular Surface Index Change from Baseline
timeFrame: on baseline and day36
measure: Tear Osmolality Change from Baseline
timeFrame: on baseline and day36
measure: Serum Biochemical Test
timeFrame: on baseline and day36
Secondary outcomes:
measure: Ocular Surface Impression Cytology Change from Baseline
timeFrame: on baseline and day36
measure: Ocular Surface Disease Index Score Change from Baseline
timeFrame: on baseline and day36
measure: Intraocular Pressure Change from Baseline
timeFrame: on baseline and day36
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Jen-Ai Hospital
Study officials:
affiliation: Chung Shan Medical University
name: David Pei-Cheng Lin
role: PRINCIPAL_INVESTIGATOR
References:
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