NCT07737938

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

Eye FatigueProbioticsDigital Eye StrainBlue Light

Outcome Measures

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.

    Baseline, Week 6, Week 12

Secondary Outcomes (8)

  • Ocular Surface Disease Index (OSDI)

    Baseline, Week 6, Week 12

  • Basic vision examination

    Baseline and Week 12

  • Pupillary Response Test

    Baseline and Week 12

  • Tear Secretion Assessment

    Baseline and Week 12

  • Non-Invasive Tear Break-Up Time (NIBUT)

    Baseline and Week 12

  • +3 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Subjects assigned to the placebo group will take one placebo capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.

Dietary Supplement: Placebo

BL531_low dose

EXPERIMENTAL

Subjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.

Dietary Supplement: BL531_low dose

BL531_high dose

EXPERIMENTAL

Subjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.

Dietary Supplement: BL531_high dose

LR1349_low dose

EXPERIMENTAL

Subjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.

Dietary Supplement: LR1349_low dose

LR1349_high dose

EXPERIMENTAL

Subjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period.

Dietary Supplement: LR1349_high dose

Interventions

PlaceboDIETARY_SUPPLEMENT

Maltodextrin

Placebo
BL531_low doseDIETARY_SUPPLEMENT

1×10\^10 cfu/day

BL531_low dose
BL531_high doseDIETARY_SUPPLEMENT

2.5×10\^10 cfu/day

BL531_high dose
LR1349_low doseDIETARY_SUPPLEMENT

1×10\^10 cfu/day

LR1349_low dose
LR1349_high doseDIETARY_SUPPLEMENT

2.5×10\^10 cfu/day

LR1349_high dose

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations