Health TrialsbyHealthPanel

Lactic Acid Bacteria for Reducing Blue Light-Induced Eye Fatigue

ConditionDigital Eye Strain (DES)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorSynbio Tech Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Dietary supplement

    Maltodextrin

  • BL531_low dose

    Dietary supplement

    1×10\^10 cfu/day

  • BL531_high dose

    Dietary supplement

    2.5×10\^10 cfu/day

  • LR1349_low dose

    Dietary supplement

    1×10\^10 cfu/day

  • LR1349_high dose

    Dietary supplement

    2.5×10\^10 cfu/day

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: BL531_low doseExperimental treatment 1 intervention
Group C: BL531_high doseExperimental treatment 1 intervention
Group D: LR1349_low doseExperimental treatment 1 intervention
Group E: LR1349_high doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Computer Vision Syndrome Questionnaire (CVS-Q)

The CVS-Q is a questionnaire used to assess digital eye strain associated with prolonged digital screen use. It includes 16 symptoms related to screen exposure. Total scores are classified as 0-5 (none/minimal), 6-12 (mild), 13-18 (moderate), and ≥19 (severe), with scores ≥6 indicating clinically significant digital eye strain.

Time frame
Baseline, Week 6, Week 12

Secondary outcomes

1

Ocular Surface Disease Index (OSDI)

The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire used to assess the severity of dry eye symptoms and their impact on vision-related function and daily activities. Total scores range from 0 to 100, with higher scores indicating greater symptom severity.

Time frame
Baseline, Week 6, Week 12
2

Basic vision examination

A comprehensive ophthalmic examination will be performed, including uncorrected distance and near visual acuity, automated refraction, presbyopia assessment, distance and near vision correction, intraocular pressure measurement, and external eye photography for conjunctival hyperemia assessment.

Time frame
Baseline and Week 12
3

Pupillary Response Test

Pupillary response testing will be performed using the Oculus Pentacam HR or an equivalent device to evaluate pupil size and response time under light and dark conditions. This assessment provides information on the visual system's adaptation to changes in illumination.

Time frame
Baseline and Week 12
4

Tear Secretion Assessment

Tear meniscus height will be measured using the OS1000 Corneal Topographer (SBM sistemi, Italy) or an equivalent device as an indicator of tear secretion.

Time frame
Baseline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Synbio Tech Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: