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RECRUITING

NCT07298824

PHASE2

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

Sponsor: Second Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

Summary

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

Official title: Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Key Details

Gender

All

Age Range

3 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2025-12-01

Completion Date

2027-07-30

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Myopia Progressing

Interventions

BIOLOGICAL

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 (from Month 3 to Month 6 of the study).

OTHER

Placebo for MR-61

Oral administration of a matched placebo powder. Dosage: one sachet, 2-3 times daily, for 3 months (from Month 3 to Month 6 of the study).

* 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. No history of orthokeratology (Ortho-K) or defocus spectacle lens wear. 5. Best-corrected distance visual acuity (BCDVA) ≥ 1.0 (decimal notation) in both eyes. 6. The subject has sufficient compliance with the study follow-up. 7. Participant or legal guardian has treatment willingness and provides written informed consent. 8. Other conditions inconsistent with this study. * Exclusion Criteria: 1. Any other concurrent ocular diseases, including various inflammations such as uveitis, glaucoma, cataract, fundus diseases, ocular tumors, or any ocular pathology affecting visual function. 2. Abnormal findings on clinical slit-lamp examination. 3. Presence of amblyopia, manifest strabismus, esotropia, or other congenital ocular diseases. 4. Abnormal intraocular pressure (IOP) or abnormal axial length (AL). 5. Either or both parents with a spherical equivalent (SE) ≤ -6.00 D. 6. Sucrose intolerance, fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency; or known allergy to any component of the investigational product. 7. Any uncontrolled clinical conditions (e.g., severe psychiatric, neurological, cardiovascular, respiratory, or hematological diseases, or malignant tumors). 8. Active ocular or systemic infection, including fever, or currently receiving antibiotic therapy. 9. Participation in any myopia control clinical trial within the past 3 months or currently participating in one. 10. Previous or current use of rigid gas permeable (RGP) contact lenses (including care products), multifocal contact lenses, progressive multifocal spectacle lenses, or other specially designed myopia control lenses, light therapy devices (e.g., repeated low-level red-light therapy), or low-concentration atropine. 11. History of systemic use of antidepressants, antihistamines, anticholinergics, antipsychotics, diuretics, contraceptives, systemic chemotherapeutic agents, sex hormones, or immunomodulators within the past 2 months. 12. Poor lifestyle habits or environment: smoking, alcohol abuse, etc. 13. Any other conditions deemed unsuitable for this study by the investigators.

Locations (1)

Yifeng Yu

Nanchang, Jiangxi, China