Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059247) titled 'A clinical study of VisionGuard Pro nutritional jelly for slowing myopia progression in children' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Acikgoz LLC FZE
Condition:
Condition - Progressive myopia in children aged from 6 to 12 years
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 6
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 Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 01 Day
Anticipated trial start date - 2026 Year 02 Month 01 Day
Last follow-up date - 2026 Year 06 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067762
Disclaimer: Curated by HT Syndication.