An interventional study of Probiotics and Placebo 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 2025-09-26.
Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Treatment
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.
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 88 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Chung Shan Medical University is the lead sponsor of 125 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Subjects will take a capsule of containing microcrystalline cellulose per day for 35 days.
Dietary Supplement: Placebo
Subjects will take a capsule of containing Streptococcus thermophilus per day for 35 days.
Dietary Supplement: Probiotics
A specific probiotics capsule product, containing Streptococcus thermophilus will be given to participants for oral intake for 35 days.
A specific capsule product, containing microcrystalline cellulose will be given to participants for oral intake for 35 days.
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.
Time frame: 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.
Time frame: 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.
Time frame: on baseline and day36
Tear Osmolality Change from Baseline
Tear osmolality is used as a parameter of dry eye status.
Time frame: 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.
Time frame: on baseline and day36
Ocular Surface Impression Cytology Change from Baseline
To assess the status of conjunctival goblet cells and epithelium.
Time frame: 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.
Time frame: on baseline and day36
Intraocular Pressure Change from Baseline
To determine the effects of intervention on intraocular pressure.
Time frame: on baseline and day36
Plan to share: No
Ran from May 2023 to primary completion in Aug 2023, 3 months.
Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's 3 months is below that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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