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Topical 0.01% Atropine for the Control of Fast Progressing Myopia (Myopie-STOP)

Primary Purpose

Myopia Progressing, Childhood

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Atropine 0.01%
Placebo
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia Progressing focused on measuring Myopia (Progressing), Childhood, Atropine 0,01%

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children from 4 to 12 years

  • Myopia from -1 to -6
  • Fast progressing myopia (>0.75 diopter / year)
  • Informed consent obtained

Exclusion Criteria:

Astigmatism > 1.5 diopters

  • Anisometropia > 2 diopters
  • Concomitant pathology of anterior or posterior segments
  • Other ocular diseases (Ocular inflammation, strabismus …)
  • Atropine hypersensitivity or allergy

Sites / Locations

  • CHU de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atropine 0.01%

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Myopia in spherical diopters
Automatic measurement of myopia in spherical diopters under cycloplegia
Myopia in spherical diopters
Automatic measurement of myopia in spherical diopters under cycloplegia
Myopia in spherical diopters
Automatic measurement of myopia in spherical diopters under cycloplegia
Myopia in spherical diopters
Automatic measurement of myopia in spherical diopters under cycloplegia

Secondary Outcome Measures

Axial length
Axial length
Axial length
Axial length
Adverse events
Adverse events
Adverse events
Adverse events
Quality of life questionnaire
Quality of life questionnaire
Quality of life questionnaire
Quality of life questionnaire

Full Information

First Posted
November 20, 2019
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT04173780
Brief Title
Topical 0.01% Atropine for the Control of Fast Progressing Myopia
Acronym
Myopie-STOP
Official Title
Topical 0.01% Atropine for the Control of Fast Progressing Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

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

5. Study Description

Brief Summary
Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular. The management of myopia and its complications is therefore a major public health issue. All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia. The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia Progressing, Childhood
Keywords
Myopia (Progressing), Childhood, Atropine 0,01%

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atropine 0.01%
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atropine 0.01%
Intervention Description
1 drop per day in both eyes for 1 year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 drop per day in both eyes for 1 year
Primary Outcome Measure Information:
Title
Myopia in spherical diopters
Description
Automatic measurement of myopia in spherical diopters under cycloplegia
Time Frame
12 months
Title
Myopia in spherical diopters
Description
Automatic measurement of myopia in spherical diopters under cycloplegia
Time Frame
9 months
Title
Myopia in spherical diopters
Description
Automatic measurement of myopia in spherical diopters under cycloplegia
Time Frame
6 months
Title
Myopia in spherical diopters
Description
Automatic measurement of myopia in spherical diopters under cycloplegia
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Axial length
Time Frame
12 months
Title
Axial length
Time Frame
6 months
Title
Axial length
Time Frame
3 months
Title
Axial length
Time Frame
9 months
Title
Adverse events
Time Frame
12 months
Title
Adverse events
Time Frame
9 months
Title
Adverse events
Time Frame
6 months
Title
Adverse events
Time Frame
3 months
Title
Quality of life questionnaire
Time Frame
12 months
Title
Quality of life questionnaire
Time Frame
9 months
Title
Quality of life questionnaire
Time Frame
6 months
Title
Quality of life questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children from 4 to 12 years Myopia from -1 to -6 Fast progressing myopia (>0.75 diopter / year) Informed consent obtained Exclusion Criteria: Astigmatism > 1.5 diopters Anisometropia > 2 diopters Concomitant pathology of anterior or posterior segments Other ocular diseases (Ocular inflammation, strabismus …) Atropine hypersensitivity or allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud SAUER, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Topical 0.01% Atropine for the Control of Fast Progressing Myopia

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