Digital Eye Strain (DES)NCT07737938
Lactic Acid Bacteria for Reducing Blue Light-Induced Eye Fatigue
A study testing BL531_low dose, BL531_high dose and LR1349_low dose in people with Digital Eye Strain (DES), run by Synbio Tech Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digital Eye Strain (DES)
- What is being tested?
- BL531_low dose, BL531_high dose and LR1349_low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Allergy to probiotics or study product ingredients
- Eating disorders, psychiatric illness, or cognitive impairment affecting compliance
- Any condition judged unsuitable by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan Normal University
Taipei, 106
Chi-Hao Wu, Professor, +886-02-7749-1427, chwu@ntnu.edu.tw
About this study
Official title: The Application of Lactic Acid Bacteria on Reducing Blue Light-Induced Eye Fatigue in Middle-Aged Adults
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.
- Conditions
- Digital Eye Strain (DES)
- Being tested
- Placebo, BL531_low dose, BL531_high dose, LR1349_low dose, LR1349_high dose
- Keywords
- Eye Fatigue, Probiotics, Digital Eye Strain, Blue Light
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Maltodextrin
BL531_low doseDietary supplement
1×10^10 cfu/day
BL531_high doseDietary supplement
2.5×10^10 cfu/day
LR1349_low doseDietary supplement
1×10^10 cfu/day
LR1349_high doseDietary supplement
2.5×10^10 cfu/day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: LR1349_high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 6, Week 12
Secondary outcomes (8)
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.
Measured: Baseline, Week 6, Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
Non-Invasive Tear Break-Up Time (NIBUT)
Non-invasive tear break-up time (NIBUT) will be measured using the OS1000 Corneal Topographer (SBM sistemi, Italy) or an equivalent device to evaluate tear film stability. A shorter NIBUT is commonly associated with dry eye symptoms and digital eye strain.
Measured: Baseline and Week 12
Corneal Tomography and Topography Analysis
Corneal tomography and topography analysis will be performed using the Oculus Pentacam HR or an equivalent device to evaluate corneal morphology, curvature, thickness, and regularity.
Measured: Baseline and Week 12
Accommodative Function Assessment
Accommodative function will be assessed using the ARK-1s Auto Ref-Keratometer (NIDEK, Japan) or an equivalent device to evaluate the eye's focusing ability and quantify accommodative responses associated with ciliary muscle contraction and relaxation.
Measured: Baseline and Week 12
Worth Four Dot Test
The Worth Four Dot Test will be used to assess binocular vision and fusion ability by evaluating responses to red and green visual targets, including the presence of suppression or diplopia.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Eye Strain (DES)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synbio Tech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737938
- Sponsor's protocol ID
- C202605115
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Lactic Acid Bacteria on Reducing Blue Light-Induced Eye Fatigue in Middle-Aged Adults
- ClinicalTrials.gov ID
- NCT07737938
- Acronym / sponsor ID
- C202605115
- Conditions
- Digital Eye Strain (DES)
- Keywords
- Eye Fatigue, Probiotics, Digital Eye Strain, Blue Light
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Synbio Tech Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects assigned to the placebo group will take one placebo capsule daily within 30 minutes before breakfast throughout the 12-week intervention period. |
| BL531_low dose | Experimental | Dietary Supplement: BL531_low doseSubjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period. |
| BL531_high dose | Experimental | Dietary Supplement: BL531_high doseSubjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period. |
| LR1349_low dose | Experimental | Dietary Supplement: LR1349_low doseSubjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period. |
| LR1349_high dose | Experimental | Dietary Supplement: LR1349_high doseSubjects assigned to each intervention group will take one capsule daily within 30 minutes before breakfast throughout the 12-week intervention period. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMaltodextrin | Dietary supplement | Placebo |
| BL531_low dose1×10^10 cfu/day | Dietary supplement | BL531_low dose |
| BL531_high dose2.5×10^10 cfu/day | Dietary supplement | BL531_high dose |
| LR1349_low dose1×10^10 cfu/day | Dietary supplement | LR1349_low dose |
| LR1349_high dose2.5×10^10 cfu/day | Dietary supplement | LR1349_high dose |
Primary outcome
Computer Vision Syndrome Questionnaire (CVS-Q)
Time frame: Baseline, Week 6, Week 12
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
Related trials for Digital Eye Strain (DES)
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Study of Eye Fatigue From Digital Screens and Its Impact on Visual Performance in People With Normal Vision and Myopia, With and Without Dry Eye Symptoms and Signs
Myopia, Dry Eye Disease (DED)
Recruiting
Efficacy of Investigator Product for the Amelioration of Digital Eye Strain in Children
Digital Eye Strain (DES)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BL531_low dose, BL531_high dose and LR1349_low dose in people with Digital Eye Strain (DES), run by Synbio Tech Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han-Yin Hsu (+886-07-6955680 Ext. 2923, hanin@synbiotech.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computer Vision Syndrome Questionnaire (CVS-Q) (time frame: Baseline, Week 6, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.