UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059247 |
|---|---|
| Receipt number | R000067762 |
| Scientific Title | A 12-Week, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of VisionGuard Pro Marine Collagen-Based Nutritional Jelly in Children With Progressive Myopia |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/30 18:42:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study of VisionGuard Pro nutritional jelly for slowing myopia progression in children
Acronym
VGP-Myopia
Scientific Title
A 12-Week, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy
and Safety of VisionGuard Pro Marine Collagen-Based Nutritional Jelly in Children With
Progressive Myopia
Scientific Title:Acronym
VisionGuard Pro in myopic children: efficacy and safety
Region
| Asia(except Japan) |
Condition
Condition
Progressive myopia in children aged from 6 to 12 years
Classification by specialty
| Pediatrics | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of VisionGuard Pro marine collagen-based nutritional jelly in slowing progression of myopia in children over 12 weeks, as assessed by change in axial length compared with placebo.
Basic objectives2
Others
Basic objectives -Others
To assess effects on choroidal thickness, macular pigment optical density, accommodative function, and contrast sensitivity.
To evaluate bioavailability of active nutrients via serum biomarkers (e.g., MMP-2, MMP-9, oxidative stress markers, nutrient levels).
To assess tolerability, compliance, and acceptability of the jelly formulation in children.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Change in axial length (mm), measured by optical biometry (e.g., IOLMaster or equivalent device), at baseline and 12 weeks.
Key secondary outcomes
Choroidal thickness, measured using enhanced depth imaging OCT, at baseline and 12 weeks.
Macular pigment optical density (MPOD), assessed by heterochromatic flicker photometry or equivalent, at baseline and 12 weeks.
Accommodation amplitude and facility, measured with standard optometric methods, at baseline and 12 weeks.
Contrast sensitivity, evaluated using Pelli-Robson chart, at baseline and 12 weeks.
Biomarkers: Serum levels of MMP-2, MMP-9, oxidative stress markers, and plasma concentrations of lutein, zeaxanthin, and DHA, at baseline and 12 weeks.
Safety and tolerability: Incidence of adverse events (AEs), gastrointestinal tolerance, and adherence (compliance rate via dose-counting).
Child acceptability/compliance, measured with standardized parental questionnaire and remaining product count.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Arm 1 Intervention
Name: VisionGuard Pro marine collagen nutritional jelly
Type: Dietary supplement / nutritional product
Dose & regimen: 1 sachet (15 g) orally once daily for 12 weeks
Packaging: Identical single-dose sachets; flavor/color matched to placebo
Compliance: Sachet count and diary
Concomitant restrictions: No myopia-control therapies (atropine, ortho-K, dual-focus lenses) during study
Interventions/Control_2
Arm 2 Control
Name: Placebo jelly
Type: Placebo control
Dose & regimen: 1 sachet (15 g) orally once daily for 12 weeks
Description: Identical appearance, texture, and taste; no active nutrients
Compliance: Sachet count + diary
Sample size
Per arm: 40 participants
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged from 6 to 12 years.
Diagnosis of progressive myopia (0.50 D progression in the past 12 months or axial length
increase more that 0.2 mm/year).
Spherical equivalent refractive error between minus 1.00 D and minus 6.00 D at baseline.
Best-corrected visual acuity of 20/25 (0.8 decimal) or better in each eye.
General good health without systemic or ocular disease affecting visual development.
Willingness of both participant and parent/guardian to provide informed consent and comply
with study protocol.
Key exclusion criteria
Previous or current use of myopia control therapies (atropine, orthokeratology, specialized
contact lenses).
Ocular pathology other than myopia (e.g., amblyopia, strabismus, keratoconus, retinal disease).
History of systemic disease that may affect vision (e.g., diabetes, connective tissue disorders).
Known allergy or intolerance to any components of the investigational or placebo jelly.
Participation in another interventional clinical trial within the past 3 months.
Inability of participant or parent/guardian to comply with study procedures.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Guzel |
| Middle name | |
| Last name | Bikbova |
Organization
Fusion Inc
Division name
Research and Development
Zip code
100-0005
Address
Tokyo,Chiyoda-ku, 2-3-2 Marunouchi, Level 1 Yusen Building
TEL
08046316681
gbikbova@fusion-edu.com
Public contact
Name of contact person
| 1st name | Guzel |
| Middle name | |
| Last name | Bikbova |
Organization
Fusion Inc
Division name
Research and Develpment
Zip code
100-0005
Address
Tokyo,Chiyoda-ku, 2-3-2 Marunouchi, Level 1 Yusen Building
TEL
08046316681
Homepage URL
gbikbova@fusion-edu.com
Sponsor or person
Institute
Acikgoz LLC FZE
Institute
Department
Personal name
Guzel Acikgoz
Funding Source
Organization
Acikgoz LLC FZE
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
UAE
Other related organizations
Co-sponsor
Fusion Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ufa Eye Research Institute of Bashkir State Medical University at the Ministry of Healthcare of the Russian Federation
Address
90 Pushkin st., Ufa, Russia, 450008
Tel
+7 (347) 286-5303
eye@bashgmu.ru
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067762
