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

NCT07298824 | Recruiting Phase 2 DMC

• 1 other identifier: IIT-I-2025-082
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia Progressing

Keywords

Myopia,Probiotics,Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Change in Spherical Equivalent Refraction

  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.

  Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

Secondary Outcomes (14)

• Change in Axial Length

  Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

• Change in Corneal Curvature

  Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

• Change in Binocular Anisometropia

  Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

• Change in Anterior Chamber Depth

  Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

• Change in Lens Thickness

  Measured at baseline, 1, 3, 6, 9, 12, 13, 14, 19, and 25 months post-intervention.

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

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

Biological: Investigational Bifidobacterium Preparation MR-61

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo for MR-61

Interventions

Investigational Bifidobacterium Preparation MR-61 BIOLOGICAL

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

Probiotic group

Placebo for MR-61 OTHER

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

Placebo group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Myopia is defined as spherical equivalent (SE) ≤ -0.5D.
• Aged between 3 and 18 years, with no restriction on gender.
• Cylinder power ≤ 1.50D; anisometropia of SE between both eyes ≤ 1.50D.
• 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.

You may not qualify if:

• Presence of other concomitant ocular diseases;
• Abnormal findings on clinical slit-lamp examination;
• Existence of amblyopia, manifest strabismus, esotropia, or other congenital ocular diseases;
• Individuals with abnormal intraocular pressure or abnormal axial length of the eye;
• Either or both parents having a spherical equivalent (SE) ≤ -6.00D;
• Other conditions inconsistent with this study.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

Yifeng Yu

Nanchang, Jiangxi, 330008, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Yifeng Yu, Ph.D

CONTACT

13979180258; 171018170@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Ph.D.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 23, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CN (1)