MyopiaPhase 3NCT04338373
Effectiveness of 0.01% Atropine Sulfate Solution in Controlling of Myopia Progression in Children
A Phase 3 study testing 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in people with Myopia, run by The V.P. Vyhodcev Eye Hospital at 1 site in Russia.
Trial summary
Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Myopia
- What is being tested?
- 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 17 Feb 2020to Aug 2021
- Phase
- Phase 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- myopia progression rate of 0.5D or more per year;
- myopia with astigmatism of 1.0D or less;
- axial length and cycloplegic refraction data obtained 6 months before recruiting or earlier
- signed informed consent.
Who cannot join
- congenital myopia;
- onset of myopia at 6 years old or earlier;
- allergic reactions to any eye drops in anamnesis;
- concomitant eye disorders, including strabismus.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
The V.P. Vyhodcev Eye Hospital
Omsk, 644024
Daria S Afanasyeva, MD, PhD, +79835279729 ext. +79852731785, ada-tomsk@yandex.ru
Konstantin S Shchukin, MD, +79236789231 ext. Afanasyeva, lek.okob@inbox.ru
About this study
Official title: Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children
Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. This open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in Russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.
Read the detailed description
The study is designed to test the following hypotheses:
- 0.01% atropine one drop nightly is safe and with no significant side effects.
- nightly instillations of 0.01% atropine does not influence tear production.
- 0.01% atropine one drop nightly reduces the progression of childhood myopia in Russian children.
- nightly instillations of 0.01% atropine decreases the manifest refraction and, consequently, difference between manifest and cycloplegic refractions.
- effectiveness of 0.01% atropine depends on the age and myopia progression rate at the time the therapy was started.
- Conditions
- Myopia
- Being tested
- 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)
- Keywords
- myopia, low dose atropine, progressive myopia, atropine in non-asian population
- Medical subject headings
- Myopia, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)Combination product
nightly instillations of 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in both eyes for 12 months
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | 0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes Receives: Combination Product: 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in axial length
Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data
Measured: baseline - 12 months
change in myopic progression rate
Change in myopic progression rate measured as the difference between cycloplegic refraction from baseline to 12 months, compared with historical data.
Measured: baseline - 12 months
Secondary outcomes (3)
change in difference between manifest and cycloplegic refractions
change in difference between manifest and cycloplegic (tropicamide 0.5%) refractions, measured with autorefractometer, compared with historical data
Measured: baseline - 12 months
change in positive relative accommodation
change in positive relative accommodation, measured in maximal spectacles correction by using concave lenses until the image blurs
Measured: baseline - 12 months
tear production
result of Schirmer I test
Measured: baseline - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start17 Feb 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open prospective clinical trial with historical control
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The V.P. Vyhodcev Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daria Afanasyeva, The V.P. Vyhodcev Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338373
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Apr 2020
- First submitted
- 4 Apr 2020
- Last updated
- 9 Apr 2020
- 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 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Prospective With Historical Control Clinical Study of 0.01 % Atropine Sulfate Effectiveness in Controlling of Myopia Progression in Children
- ClinicalTrials.gov ID
- NCT04338373
- Acronym / sponsor ID
- 2020-01
- Conditions
- Myopia
- Keywords
- myopia, low dose atropine, progressive myopia, atropine in non-asian population
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The V.P. Vyhodcev Eye HospitalUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 8 Apr 2020 (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.
Increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. Instillations of low-dose atropine have been shown to reduce myopia progression in Asian populations but its effect in non-Asian populations is still unclear. This open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in Russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.
Detailed description
The study is designed to test the following hypotheses:
- 0.01% atropine one drop nightly is safe and with no significant side effects.
- nightly instillations of 0.01% atropine does not influence tear production.
- 0.01% atropine one drop nightly reduces the progression of childhood myopia in Russian children.
- nightly instillations of 0.01% atropine decreases the manifest refraction and, consequently, difference between manifest and cycloplegic refractions.
- effectiveness of 0.01% atropine depends on the age and myopia progression rate at the time the therapy was started.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open prospective clinical trial with historical control
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Combination Product: 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)0.01% Atropine Sulfate solution in "Comfort Drops", nightly instillations to both eyes |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- myopia progression rate of 0.5D or more per year;
- myopia with astigmatism of 1.0D or less;
- axial length and cycloplegic refraction data obtained 6 months before recruiting or earlier
- signed informed consent.
Key exclusion criteria (4 listed)
- congenital myopia;
- onset of myopia at 6 years old or earlier;
- allergic reactions to any eye drops in anamnesis;
- concomitant eye disorders, including strabismus.
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 |
|---|---|---|
| 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain)nightly instillations of 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in both eyes for 12 months | Combination product | experimental |
Primary outcome
change in axial length
Time frame: baseline - 12 months
Change in axial length elongation from baseline to 12 months, as measured using IOLMaster, compared with historical data
change in myopic progression rate
Time frame: baseline - 12 months
Change in myopic progression rate measured as the difference between cycloplegic refraction from baseline to 12 months, compared with historical data.
3 secondary outcomes
change in difference between manifest and cycloplegic refractions
Time frame: baseline - 12 months
change in positive relative accommodation
Time frame: baseline - 12 months
tear production
Time frame: baseline - 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.01% Atropine sulfate solution in "Comfort Drops" ("AVIZOR S.A.", Spain) in people with Myopia, run by The V.P. Vyhodcev Eye Hospital at 1 site in Russia.
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 4 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: status not confirmed, as of the sponsor's last update on 9 Apr 2020. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in axial length (time frame: baseline - 12 months). The study lists 2 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 9 Apr 2020.