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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Childhood; Myopia Progressing
• Intervention / Treatment: Drug: Atropine 0.01%; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Arnaud SAUER, MD; Phone Number: 0033 03 69 55 02 70; Email: arnaud.sauer@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • chu de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 1 drop per day in both eyes for 1 year
Experimental: Atropine 0.01%	Drug: Atropine 0.01%; 1 drop per day in both eyes for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myopia in spherical diopters	Automatic measurement of myopia in spherical diopters under cycloplegia	12 months
Myopia in spherical diopters	Automatic measurement of myopia in spherical diopters under cycloplegia	9 months
Myopia in spherical diopters	Automatic measurement of myopia in spherical diopters under cycloplegia	6 months
Myopia in spherical diopters	Automatic measurement of myopia in spherical diopters under cycloplegia	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	3 months
Adverse events	12 months
Adverse events	6 months
Axial length	12 months
Axial length	6 months
Axial length	3 months
Axial length	9 months
Adverse events	9 months
Quality of life questionnaire	12 months
Quality of life questionnaire	9 months
Quality of life questionnaire	6 months
Quality of life questionnaire	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Arnaud SAUER, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Childhood; Myopia (Progressing); Atropine 0,01%
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: 7343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No