Dry Eye Symptom Mitigation by Oral Intake of Probiotics

Study Overview
=================
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.

Official Title
-----------------
A Clinical Trial of Dry Eye Symptom Mitigation by Oral Intake of Probiotics

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Subjects will take a capsule of containing microcrystalline cellulose per day for 35 days. | Dietary Supplement: Placebo<br>* A specific capsule product, containing microcrystalline cellulose will be given to participants for oral intake for 35 days.<br>|
| Experimental: Treatment group<br>Subjects will take a capsule of containing Streptococcus thermophilus per day for 35 days. | Dietary Supplement: Probiotics<br>* A specific probiotics capsule product, containing Streptococcus thermophilus will be given to participants for oral intake for 35 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Schirmer's Test Value from Baseline | The Schirmer's Test is used to assess tear secretion volume. The amounts of tears are measured in total millimeters after 5 minutes has elapsed. Lower measurement amount is regarded as a parameter of presence of dry eye disease. | on baseline and day36 | 
| Change of Tear Film Breakup Time from Baseline | Tear Break-Up Time is a measurement to reflect tear quality and is expressed in seconds. The shorter the Tear Break-Up Time, the poorer the tear film stability and quality. Lower measurement outcome (less than 10 seconds) is regarded as a parameter of presence of dry eye disease. | on baseline and day36 | 
| Ocular Surface Index Change from Baseline | Ocular Surface Index is assessed with fluorescein staining to reflect ocular surface damages. The staining scale ranges from 0 to 3, from milder to severe status, where grade 0 shows no staining, and grade 3 shows extensive staining. | on baseline and day36 | 
| Tear Osmolality Change from Baseline | Tear osmolality is used as a parameter of dry eye status. | on baseline and day36 | 
| Serum Biochemical Test | To determine the effects of oral probiotics intake on the contents of hyaluronic acid, sialic acid, and glutathione in the serum. | on baseline and day36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Impression Cytology Change from Baseline | To assess the status of conjunctival goblet cells and epithelium. | on baseline and day36 | 
| Ocular Surface Disease Index Score Change from Baseline | A questionnaire is used to assess the health status on ocular surface, with higher scores indicating more severe status. | on baseline and day36 | 
| Intraocular Pressure Change from Baseline | To determine the effects of intervention on intraocular pressure. | on baseline and day36 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
probiotics, dry eye, eye sore, eye strain