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Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents (LAMC)

Primary Purpose

Myopia, Progressive

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low concentration atropine (0.01%)
low concentration atropine (0.025%)
low concentration atropine (0.05%)
Placebo
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The age of the screening stage is 3-15 years, both sexes;
  2. One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
  3. Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
  4. Informed consent from the guardian and the child.

Exclusion Criteria:

  1. strabismus, amblyopia or other ocular abnormalities;
  2. The presence of systemic disease abnormalities;
  3. have taken myopia control treatment in the past month;
  4. Allergic to low concentration atropine or sulfuric acid drugs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Other

    Arm Label

    0.01% atropine

    0.025% atropine

    0.05% atropine

    cross-over

    Arm Description

    0.01% atropine eye drop

    0.025% atropine eye drop

    0.05% atropine eye drop

    first year: placebo second year: 0.05% atropine eye drop

    Outcomes

    Primary Outcome Measures

    Proportion of SE changes over -0.75D

    Secondary Outcome Measures

    AL change

    Full Information

    First Posted
    October 24, 2022
    Last Updated
    January 9, 2023
    Sponsor
    Shanghai Eye Disease Prevention and Treatment Center
    Collaborators
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Peking University People's Hospital, Shandong University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05597163
    Brief Title
    Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
    Acronym
    LAMC
    Official Title
    A Multicenter, Double-blind, Randomized, Controlled Clinical Study of the Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Eye Disease Prevention and Treatment Center
    Collaborators
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Peking University People's Hospital, Shandong University of Traditional Chinese Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Progressive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    588 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    0.01% atropine
    Arm Type
    Experimental
    Arm Description
    0.01% atropine eye drop
    Arm Title
    0.025% atropine
    Arm Type
    Experimental
    Arm Description
    0.025% atropine eye drop
    Arm Title
    0.05% atropine
    Arm Type
    Experimental
    Arm Description
    0.05% atropine eye drop
    Arm Title
    cross-over
    Arm Type
    Other
    Arm Description
    first year: placebo second year: 0.05% atropine eye drop
    Intervention Type
    Drug
    Intervention Name(s)
    low concentration atropine (0.01%)
    Intervention Description
    0.01% atropine eye drop
    Intervention Type
    Drug
    Intervention Name(s)
    low concentration atropine (0.025%)
    Intervention Description
    0.025% atropine eye drop
    Intervention Type
    Drug
    Intervention Name(s)
    low concentration atropine (0.05%)
    Intervention Description
    0.05% atropine eye drop
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo eye drop
    Primary Outcome Measure Information:
    Title
    Proportion of SE changes over -0.75D
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    AL change
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The age of the screening stage is 3-15 years, both sexes; One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8; Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required; Informed consent from the guardian and the child. Exclusion Criteria: strabismus, amblyopia or other ocular abnormalities; The presence of systemic disease abnormalities; have taken myopia control treatment in the past month; Allergic to low concentration atropine or sulfuric acid drugs.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haidong Zou
    Phone
    +86021-53555032
    Email
    dllcrco@shsyf.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Haidong Zou
    Organizational Affiliation
    Shanghai Eye Disease Prevention and Treatment Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

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