Myopia ProgressingPhase 2/3Myopie-STOPNCT04173780
Topical 0.01% Atropine for the Control of Fast Progressing Myopia
A Phase 2/3 study testing Atropine 0.01% in people with Myopia Progressing and Childhood, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Myopia Progressing, Childhood
- What is being tested?
- Atropine 0.01%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2020to 3 Jun 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 4 to 12 years
- Myopia from -1 to -6
- Fast progressing myopia (>0.75 diopter / year)
- Informed consent obtained
Who cannot join
- Astigmatism > 1.5 diopters
- Anisometropia > 2 diopters
- Concomitant pathology of anterior or posterior segments
- Other ocular diseases (Ocular inflammation, strabismus …)
- Atropine hypersensitivity or allergy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Atropine 0.01%, Placebo
- Keywords
- Myopia (Progressing), Childhood, Atropine 0,01%
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine 0.01%Drug
1 drop per day in both eyes for 1 year
PlaceboDrug
1 drop per day in both eyes for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Atropine 0.01% | Experimental | Not described Receives: Drug: Atropine 0.01% |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myopia in spherical diopters
Automatic measurement of myopia in spherical diopters under cycloplegia
Measured: 12 months
Myopia in spherical diopters
Automatic measurement of myopia in spherical diopters under cycloplegia
Measured: 9 months
Myopia in spherical diopters
Automatic measurement of myopia in spherical diopters under cycloplegia
Measured: 6 months
Myopia in spherical diopters
Automatic measurement of myopia in spherical diopters under cycloplegia
Measured: 3 months
Secondary outcomes (12)
Axial length
Measured: 12 months
Axial length
Measured: 6 months
Axial length
Measured: 3 months
Axial length
Measured: 9 months
Adverse events
Measured: 12 months
Adverse events
Measured: 9 months
Adverse events
Measured: 6 months
Adverse events
Measured: 3 months
Quality of life questionnaire
Measured: 12 months
Quality of life questionnaire
Measured: 9 months
Quality of life questionnaire
Measured: 6 months
Quality of life questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start12 Feb 2020
- Primary completion15 May 2024
- Study completion3 Jun 2024
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressingStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud SAUER, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173780
- Sponsor's protocol ID
- 7343
- Acronym
- Myopie-STOP
- Status last verified
- Aug 2024
- First submitted
- 20 Nov 2019
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 0.01% Atropine for the Control of Fast Progressing Myopia
- ClinicalTrials.gov ID
- NCT04173780
- Acronym / sponsor ID
- Myopie-STOP / 7343
- Conditions
- Myopia Progressing, Childhood
- Keywords
- Myopia (Progressing), Childhood, Atropine 0,01%
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine 0.01% | Experimental | Drug: Atropine 0.01% |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children from 4 to 12 years
- Myopia from -1 to -6
- Fast progressing myopia (>0.75 diopter / year)
- Informed consent obtained
Key exclusion criteria (5 listed)
- Astigmatism > 1.5 diopters
- Anisometropia > 2 diopters
- Concomitant pathology of anterior or posterior segments
- Other ocular diseases (Ocular inflammation, strabismus …)
- Atropine hypersensitivity or allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine 0.01%1 drop per day in both eyes for 1 year | Drug | Atropine 0.01% |
| Placebo1 drop per day in both eyes for 1 year | Drug | Placebo |
Primary outcome
Myopia in spherical diopters
Time frame: 12 months
Automatic measurement of myopia in spherical diopters under cycloplegia
Myopia in spherical diopters
Time frame: 9 months
Automatic measurement of myopia in spherical diopters under cycloplegia
Myopia in spherical diopters
Time frame: 6 months
Automatic measurement of myopia in spherical diopters under cycloplegia
Myopia in spherical diopters
Time frame: 3 months
Automatic measurement of myopia in spherical diopters under cycloplegia
12 secondary outcomes
Axial length
Time frame: 12 months
Axial length
Time frame: 6 months
Axial length
Time frame: 3 months
Axial length
Time frame: 9 months
Adverse events
Time frame: 12 months
Adverse events
Time frame: 9 months
Adverse events
Time frame: 6 months
Adverse events
Time frame: 3 months
Quality of life questionnaire
Time frame: 12 months
Quality of life questionnaire
Time frame: 9 months
Quality of life questionnaire
Time frame: 6 months
Quality of life questionnaire
Time frame: 3 months
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud SAUER, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atropine 0.01% in people with Myopia Progressing and Childhood, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myopia in spherical diopters (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.