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Not yet recruiting NCT07737938

Lactic Acid Bacteria for Reducing Blue Light-Induced Eye Fatigue

No phase Interventional Digital Eye Strain (DES)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, BL531_low dose, BL531_high dose, LR1349_low dose.
Who it may be relevant to
Registry conditions: Digital Eye Strain (DES). Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Application of Lactic Acid Bacteria on Reducing Blue Light-Induced Eye Fatigue in Middle-Aged Adults

Overview

With the widespread use of digital devices and prolonged screen exposure, digital eye strain (DES), also known as computer vision syndrome, has become a global public health concern. Emerging evidence suggests that the gut-eye axis may play an important role in ocular health, as gut microbiota imbalance is associated with systemic inflammation and oxidative stress. Specific probiotics may help alleviate eye discomfort through modulation of immune responses and enhancement of antioxidant defense mechanisms. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy of supplementation with specific probiotics, Bifidobacterium longum BL531 and Lactobacillus reuteri LR1349, in improving digital eye strain symptoms in adults.

Interventions

  • Dietary supplement Placebo
    Maltodextrin
  • Dietary supplement BL531_low dose
    1×10\^10 cfu/day
  • Dietary supplement BL531_high dose
    2.5×10\^10 cfu/day
  • Dietary supplement LR1349_low dose
    1×10\^10 cfu/day
  • Dietary supplement LR1349_high dose
    2.5×10\^10 cfu/day

Primary outcome measures

  • Computer Vision Syndrome Questionnaire (CVS-Q) [Time frame: Baseline, Week 6, Week 12]
Secondary outcome measures (8)
  • Ocular Surface Disease Index (OSDI) [Time frame: Baseline, Week 6, Week 12]
  • Basic vision examination [Time frame: Baseline and Week 12]
  • Pupillary Response Test [Time frame: Baseline and Week 12]
  • Tear Secretion Assessment [Time frame: Baseline and Week 12]
  • Non-Invasive Tear Break-Up Time (NIBUT) [Time frame: Baseline and Week 12]
  • Corneal Tomography and Topography Analysis [Time frame: Baseline and Week 12]
  • Accommodative Function Assessment [Time frame: Baseline and Week 12]
  • Worth Four Dot Test [Time frame: Baseline and Week 12]

Eligibility criteria

Inclusion criteria

  • Men and women aged 20-65 years
  • Daily digital screen use >6 hours for at least 1 year
  • Mild to severe digital eye strain (CVS-Q score ≥ 6)
  • Mild to moderate dry eye symptoms (OSDI ≥ 13)

Exclusion criteria

  • Amblyopia or strabismus
  • Severe eye diseases (e.g., glaucoma , cataract , retinal disorders, severe corneal disease)
  • Ocular surgery within the past 12 months
  • Chronic systemic diseases (e.g., uncontrolled diabetes, autoimmune disease, severe liver/kidney impairment, cancer)
  • Recent use (<1 months) of steroids, antibiotics, immunosuppressants, probiotics, prebiotics, or eye-health supplements
  • Pregnant or breastfeeding
  • Allergy to probiotics or study product ingredients
  • Eating disorders, psychiatric illness, or cognitive impairment affecting compliance
  • Any condition judged unsuitable by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Taiwan · 1 center
  • National Taiwan Normal University — Taipei

Identifiers

NCT: NCT07737938 · C202605115

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗