MyopiaEarly Phase 1NCT05778201
To Study the Effects of Baby Drink on Vision Care
A Early Phase 1 study testing Baby Drink group in people with Myopia, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Baby Drink is a formula based on lutein, mixed with blueberry fermented liquid, vitamins and minerals. Lutein is an effective antioxidant to prevent retinal damage caused by blue light, but it cannot be produced in the human body and depends on dietary intake. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Baby Drink group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Mar 2023to 31 Aug 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 20 or over
- Willing to participate in this study and sign the subject's consent form
- Myopia less than 700 degrees
Who cannot join
- Have consumed related eye care products in past 3 months
- Those who have eye infection in the past 3 months
- People who have been diagnosed with any eye diseases in past 3 months
- Those who are allergic to cicadae
Trial locations and contacts
1 site in 1 country.
About this study
Baby Drink is a formula based on lutein, mixed with blueberry fermented liquid, vitamins and minerals. Lutein is an effective antioxidant to prevent retinal damage caused by blue light, but it cannot be produced in the human body and depends on dietary intake. Blueberry fermented liquid is rich in polyphenolic compounds with excellent antioxidant capacity and the potential to reduce oxidative damage to eye cells caused by ultraviolet rays. With the prevalence of 3C products, myopia patients are increasing year by year in various regions, and suffer from eye diseases or vision loss with different degrees of complications. In this study, the subjects were provided with Baby Drink and tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. The aim of this study is to investigate the protection of Baby Drink on visual acuity and visual fatigue.
Read the detailed description
- Visual acuity measurement: Snellen's Chart was used to measure visual acuity.
- Refractive examination: Measure binocular refraction with Open Field computer refractor (Shin-Nippon Nvision K5001 Wide View).
- Measuring the axial length of the eye: Use the multifunctional optical eyeball length measuring instrument (Lenstar) to measure the distance from the instrument to the optical paths such as the cornea, lens, and retina, and then convert to the axial length of the eye.
- Corneal radian measurement: Use a keratometer (Bausch \& Lomb Keratometer) to measure the corneal radian and curvature, and estimate the degree of corneal astigmatism.
- Visual fatigue questionnaire survey: A visual fatigue scale questionnaire was designed using Ocular Surface Disease Index (OSDI) and Computer Vision Syndrome (CVS).
- Conditions
- Myopia
- Being tested
- Baby Drink group
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby Drink groupBiological
1 packge (20 ml)/ day for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Baby Drink group | Experimental | 1 package/ day for 1 month Receives: Biological: Baby Drink group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye fatigue questionnaire
- Eye fatigue were evaluated according to The Ocular Surface Disease Index (OSDI) introduced in 1997 by the Outcomes Research Group (Allergan Inc., Irvine, CA).
- Content including: (1) Eye swelling, (2) Eye soreness, (3) Photophobia, (4) Blurred vision, (5) Dry eye, (6) Foreign body sensation, (7) Tearing, (8) General discomfort related to eye fatigue.
- Scores are expressed on a scale of 0-3. 0 = No symptoms , 1 = Occasionally (≤1 time/day), 2 = Sometimes (1-3 times/day), 3 = Frequently (>3 times/day), a low score means less visual fatigue and better eye quality.
Measured: 1 month
Best vision test
- Visual acuity was tested with the Snellen Eye Test Chart and recorded with the score proposed by Snellen.
- Subjects were asked to stand 20 feet away to observe the snellen E-chart and record the smallest visual mark.
- Recording method: 20/20 (1.0) is defined as normal vision, lower than this score indicates that the subject has ametropia, and higher than this indicates that the subject's vision is higher than the general standard
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start18 Mar 2023
- Primary completion19 Apr 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Baby Drink Intervention group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Wen Lin, China Medical University Hospital
- Investigators
- Hui Wen Lin, ph.D, Principal investigator, Asia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778201
- Sponsor's protocol ID
- CRREC-111-088
- Status last verified
- Jun 2026
- First submitted
- 8 Mar 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Effects of Baby Drink on Vision Care
- ClinicalTrials.gov ID
- NCT05778201
- Acronym / sponsor ID
- CRREC-111-088
- Conditions
- Myopia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Mar 2023 (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.
Baby Drink is a formula based on lutein, mixed with blueberry fermented liquid, vitamins and minerals. Lutein is an effective antioxidant to prevent retinal damage caused by blue light, but it cannot be produced in the human body and depends on dietary intake. Blueberry fermented liquid is rich in polyphenolic compounds with excellent antioxidant capacity and the potential to reduce oxidative damage to eye cells caused by ultraviolet rays. With the prevalence of 3C products, myopia patients are increasing year by year in various regions, and suffer from eye diseases or vision loss with different degrees of complications. In this study, the subjects were provided with Baby Drink and tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. The aim of this study is to investigate the protection of Baby Drink on visual acuity and visual fatigue.
Detailed description
- Visual acuity measurement: Snellen's Chart was used to measure visual acuity.
- Refractive examination: Measure binocular refraction with Open Field computer refractor (Shin-Nippon Nvision K5001 Wide View).
- Measuring the axial length of the eye: Use the multifunctional optical eyeball length measuring instrument (Lenstar) to measure the distance from the instrument to the optical paths such as the cornea, lens, and retina, and then convert to the axial length of the eye.
- Corneal radian measurement: Use a keratometer (Bausch \& Lomb Keratometer) to measure the corneal radian and curvature, and estimate the degree of corneal astigmatism.
- Visual fatigue questionnaire survey: A visual fatigue scale questionnaire was designed using Ocular Surface Disease Index (OSDI) and Computer Vision Syndrome (CVS).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Baby Drink Intervention group
| Arm | Type | Receives |
|---|---|---|
| Baby Drink group | Experimental | Biological: Baby Drink group1 package/ day for 1 month |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20 or over
- Willing to participate in this study and sign the subject's consent form
- Myopia less than 700 degrees
Key exclusion criteria (4 listed)
- Have consumed related eye care products in past 3 months
- Those who have eye infection in the past 3 months
- People who have been diagnosed with any eye diseases in past 3 months
- Those who are allergic to cicadae
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 |
|---|---|---|
| Baby Drink group1 packge (20 ml)/ day for 1 month | Biological | Baby Drink group |
Primary outcome
Eye fatigue questionnaire
Time frame: 1 month
1. Eye fatigue were evaluated according to The Ocular Surface Disease Index (OSDI) introduced in 1997 by the Outcomes Research Group (Allergan Inc., Irvine, CA). 2. Content including: (1) Eye swelling, (2) Eye soreness, (3) Photophobia, (4) Blurred vision, (5) Dry eye, (6) Foreign body sensation, (7) Tearing, (8) General discomfort related to eye fatigue. 3. Scores are expressed on a scale of 0-3. 0 = No symptoms , 1 = Occasionally (≤1 time/day), 2 = Sometimes (1-3 times/day), 3 = Frequently (>3 times/day), a low score means less visual fatigue and better eye quality.
Best vision test
Time frame: 1 month
1. Visual acuity was tested with the Snellen Eye Test Chart and recorded with the score proposed by Snellen. 2. Subjects were asked to stand 20 feet away to observe the snellen E-chart and record the smallest visual mark. 3. Recording method: 20/20 (1.0) is defined as normal vision, lower than this score indicates that the subject has ametropia, and higher than this indicates that the subject's vision is higher than the general standard
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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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. This study is not recruiting at the moment.
Hui Wen Lin, ph.D principal investigator
Asia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Baby Drink group in people with Myopia, run by China Medical University Hospital 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye fatigue questionnaire (time frame: 1 month). The study lists 2 primary outcomes in all. 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 15 Jun 2026.