Topical 0.01% Atropine for the Control of Fast Progressing Myopia

NCT04173780 | Terminated Phase 2

• 1 other identifier: 7343
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Myopia Progressing; Childhood

Keywords

Myopia (Progressing); Childhood; Atropine 0,01%

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Axial length

  12 months

• Axial length

  6 months

• Axial length

  3 months

• Axial length

  9 months

• Adverse events

  12 months

Study Arms (2)

Atropine 0.01%

EXPERIMENTAL

Drug: Atropine 0.01%

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Atropine 0.01% DRUG

1 drop per day in both eyes for 1 year

Atropine 0.01%

Placebo DRUG

1 drop per day in both eyes for 1 year

Placebo

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children from 4 to 12 years
• Myopia from -1 to -6
• Fast progressing myopia (\>0.75 diopter / year)
• Informed consent obtained

You may not qualify if:

• Astigmatism \> 1.5 diopters
• Anisometropia \> 2 diopters
• Concomitant pathology of anterior or posterior segments
• Other ocular diseases (Ocular inflammation, strabismus …)
• Atropine hypersensitivity or allergy

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

CHU de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Arnaud SAUER, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: February 12, 2020
• Primary Completion: May 15, 2024
• Study Completion: June 3, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)