Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia

NCT07298824 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital of Nanchang University

Phase

Phase 2

Started

2025-10-01

Last updated

2025-12-23

Condition(s) studied

Myopia Progressing

Investigational drug(s) / intervention(s)

Investigational Bifidobacterium Preparation MR-61Placebo for MR-61

Investigational Bifidobacterium Preparation MR-61: Oral administration of the investigational probiotic powder MR-61. The primary component is Bifidobacterium. Dosage: one sachet, 2-3 times daily, for 3 months.

Placebo for MR-61: Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months.

Study summary

To investigate whether probiotic MR-61 can assist in slowing down the progression rate of myopia (a prospective randomized controlled study).

Eligibility

Sex

ALL

Min age

3 Years

Max age

18 Years

Healthy volunteers

Inclusion Criteria: 1. Myopia is defined as spherical equivalent (SE) ≤ -0.5D. 2. Aged between 3 and 18 years, with no restriction on gender. 3. Cylinder power ≤ 1.50D; anisometropia of SE between both eyes ≤ 1.50D. 4. The subject has sufficient compliance with the study follow-up; the subject or their guardian has the intention to receive treatment and has signed the informed consent form. Exclusion Criteria: 1. Presence of other concomitant ocular diseases; 2. Abnormal findings on clinical slit-lamp examination; 3. Existence of amblyopia, manifest strabismus, esotropia, or other congenital ocular diseases; 4. Individuals with abnormal intraocular pressure or abnormal axial length of the eye; 5. Either or both parents having a spherical equivalent (SE) ≤ -6.00D; 6. Other conditions inconsistent with this study.

Primary outcome measure(s)

Change in Spherical Equivalent Refraction — Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.
The change in spherical equivalent refraction (SER) from baseline to each follow-up visit, measured in diopters (D). SER is calculated as the spherical power plus half of the cylindrical power. A negative change indicates an increase in myopia.

Trial sites (1)

Facility	City	Region	Status
Yifeng Yu	Nanchang	Jiangxi	Recruiting

More Second Affiliated Hospital of Nanchang University trials in China

The Effect of SAAE on Ventricular Remodeling in PA Patients Recruiting

Multi-Center Registry Cohort Study on Prognostic Factors and Prediction Model Construction in Aneurysmal SAH Recruiting

Early Lumbar Drainage for Intraventricular Hemorrhage Starting soon

Clinical Study of Esketamine in Patients With Sepsis Undergoing Invasive Mechanical Ventilation Active, not recruiting

Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study Recruiting

Other trials for the same condition

Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents Active, not recruiting

Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression Active, not recruiting

3D Designed Defocus Lenses on Myopia Control in Children and Adolescents Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07298824 on ClinicalTrials.gov ↗ ← All trials in China