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.