MyopiaPhase 3MODERATONCT07028827
Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)
A Phase 3 study testing 0.05% atropine eye drops and 0.025% atropine eye drops in people with Myopia, run by Ocus Innovation Ireland Limited at 11 sites in 5 countries.
Trial summary
Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors. Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Myopia
- What is being tested?
- 0.05% atropine eye drops and 0.025% atropine eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females, aged from 3 to less than 18 years.
- Subjects showing myopia with a spherical equivalent refraction of both eyes at least -0.75 D at baseline.
- The intraocular pressure in each eye must be equal or less than 21 mmHg.
- The parents or the legal representative must be informed about the clinical trial and must sign the informed consent form. The exception to consider is related to the individuals aged above 16 years only in the UK, who can provide their own consent according to the local regulations.
- Women with childbearing potential (WOCBP) (after menarche) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy testing during the study will be conducted at visits 1, 2, 3, 4, 5, 6.
- WOCBP or males who are using a highly effective birth control method to prevent pregnancies. Eligible highly effective contraceptive methods for WOCBP are combined (which contain estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal (inside of the vagina), transdermal (through the skin)); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (small devices that are placed inside uterus to prevent pregnancies); intrauterine hormone-releasing system. Sexual abstinence represents a highly effective contraceptive method, if in line with the subject's normal habits.
Who cannot join
- Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding |1.5| D.
- Refractive astigmatism exceeding |1.5| D.
- Presence of ocular pathologies such as pathological myopia, corneal scars, or other anterior or posterior eye pathologies.
- History of amblyopia or strabismus.
- Presence of a history of a retinal dystrophy or systemic disorder that may predispose to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity)
- Abnormalities in ocular biometry, except for axial length or previous intraocular or ocular laser/non-laser surgery.
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- History of glaucoma or narrow angles in the anterior chamber of the eye.
- Conditions such as Down syndrome or spastic paralysis.
- Known intolerance or allergies to atropine eye drops or hypersensitivity to any component of the atropine eye drops.
- Pregnancy or breastfeeding.
- History of alcohol or drug abuse.
- Mental or emotional instability that could interfere with study procedures.
- Lack of reliability or cooperation from the patient.
- Any treatment received for myopia within the past three months prior to inclusion in the study.
- Other reasons, at the discretion of the investigator that may deem the subject's participation in the study inappropriate.
- Patients who have consented to participate in the clinical trial, but do not meet one or more eligibility criteria required for participation in the trial during the screening procedures, and subsequently are not randomly assigned to the study treatment or entered in the study, are considered screening failures.
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 5 countries
Italy3 sites, 3 recruiting
- Recruiting
Ophthalmology - AOU Consorziale Policlinico - Ospedale Pediatrico Giovanni XXIII
Bari
Giovanni Alessio, Ophthalmologist, +390805592435, giovanni.alessio@uniba.it
Ugo Procoli, Ophthalmologist, +390805592481 ; +390805592434, ugo.procoli@policlinico.ba.it
- Recruiting
Pediatric Ophthalmology - Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Milan
Milan
Silvia Osnaghi, MD, 0255033912, silvia.osnaghi@policlinico.mi.it
Claudia Mainetti, BSC, 0255033912, claudia.mainetti@policlinico.mi.it
- Not yet recruiting
Azienda Ospedale Università Padova
Padua
Raffaele Parrozzani, Professor, 049 821 2394, trialsoculistica@unipd.it
Evelyn Longhin, Orthoptist, +390498212110, trialsoculistica@unipd.it
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Parc Taulí
Barcelona, 08208
Marta Carrera Tarrés, Surgery and Medicine Degree, 937231010 ext. 82321, mcarrera@tauli.cat
Carlos Cuesta Acero, Surgery and Medicine Degree, 937231010 ext. 82321, ccuesta@tauli.cat
- Recruiting
Hospital Puerta del Mar (INIBICA)
Cadiz, 11009
Eduardo Alcalde Vílchez, Ophthalmologist, +34 615 709 231, alcaldevilchez@gmail.com
Emilio Cebrián Rosado, Ophthalmologist, +34 629 632 882, emiliocebrianrosado@hotmail.com
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Natalia Arruti, MD, PhD, 0034 917277258, oftal.infantil.hulp@salud.madrid.org
Yoana Blasco, Nurse, 0034 917277258, oftal.infantil.hulp@salud.madrid.org
United Kingdom3 sites, 3 recruiting
- Recruiting
Northern Ireland Clinical Research Facility. U Floor. Belfast City Hospital
Belfast, BT9 7AB
Augusto Azuara-Blanco, Clinical Professor, 028 9097 1655, a.azuara-blanco@qub.ac.uk
Emma McConnell, Research Fellow, 02895 040342, e.mcconnell@qub.ac.uk
- Recruiting
School of Optometry, Aston University
Birmingham
Nicola S Logan, PhD FCOptom, +441212044128, n.s.logan@aston.ac.uk
Susie Jones, PhD MCOptom, +441212044100, myopia@aston.ac.uk
- Recruiting
R&D, Moorfields Eye Hospital
London
Annegret Dahlmann-Noor, PhD, 020 7253 3411, annegret.dahlmann-noor@nhs.net
Elisha Pickett, moorfields.resadmin@nhs.net
Albania1 site, 1 recruiting
- Recruiting
University Hospital Centre Mother Teresa (UHCT), Paediatric Department
Tirana
Eneda Rustemi (Balliu), PhD, +35568 405 4408, eneda_rustemi@yahoo.com
Arjeta Demi (Grezda), PhD, +355 69 204 6189, arjeta_demi@yahoo.com
Poland1 site, 1 recruiting
- Recruiting
Children's Memorial Health Institute, Department of Ophthalmology
Warsaw
Mieszko Lachota, MD, PhD, +48 22 815 73 55, m.lachota@ipczd.pl
Wojciech Hautz, MD, Professor, +48 22 815 73 55, w.hautz@ipczd.pl
About this study
Official title: A Phase III, Randomized, Double-blind, Multiple Doses, Placebo-controlled, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Atropine for the Treatment of Myopia Progression in Children and Adolescents (MODERATO Study)
Myopia, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors.
Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems.
Read more
Progressive myopia is nearly exclusively a condition of childhood and adolescence, as in most young adults, myopia has stabilized.
Myopia frequently appears in childhood, with a peak incidence occurring between 8 and 10 years of age.
The most used topical pharmacological intervention for managing childhood myopia progression is atropine, a non-selective muscarinic antagonist, which has been widely used in clinical trials in concentrations ranging from 0.01% to 1.0%.
Atropine is at present the agent with the highest efficacy and optimal safety profile to reduce myopia progression in children and adolescents.
MODERATO study, a phase III, prospective, multicentric, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study, aims to evaluate the efficacy and safety of 0.025% and 0.05% atropine eye drops in children and adolescents aged 3 to under 18 years old over a 24-month period, to understand its ability to manage and stop myopia getting worse. It will be conducted in 11 centers in Italy, Spain, Poland, the UK and Albania.
Read the detailed description
The MODERATO study is a phase III, prospective, multicentric, randomized, double-blind, parallel group, adaptive, placebo-controlled trial. The study will be conducted in primary care and hospital settings in 3 European countries (Italy, Spain, Poland), in the UK and in Albania, involving a total of 11 centers.
The study hypothesis is that low dose (0.025% and 0.05%) of atropine eye drops will reduce the myopia progression in children and adolescents (3-18 years of age) compared with placebo eye drops, over 24 months.
A total of 234 participants from 5 countries will be estimated to take part in the study.
Eligible participants with myopia with a spherical equivalent refraction of both eyes at least -0.75 D at baseline will be randomized to treatment (0.025% atropine eye drops, 0.05% atropine eye drops) and placebo groups in 1:1:1 ratio. Each arm will consist of at least 78 individuals.
In this study, the primary objective is to evaluate efficacy of 0.025% and 0.05% atropine eye drops in children and adolescents over 24 months to slow the progression of myopia.
A formal interim efficacy analysis on the primary endpoint will be planned when the 50% of the total planned sample size has completed the 1-year treatment follow-up (105 evaluable patients in total: 35 in each arm).
"EARLY ESCAPE" Phase of Patients after Six Months of Atropine Eye Drops Treatment At the sixth month of treatment, if the patients who received the placebo treatment show worsening of their myopia, they will be switched to the active treatment. This approach is called "early escape", which ensures that the patients receive the best treatment as soon as possible, reducing the time during which they may receive ineffective treatment. The analysis will be conducted by a team of experts, Data Safety Monitoring Committee (DSMC). The treatment after the early escape will be carried out as open label study. Blinding will be maintained for the patients who do not early escape.
Analysis after One Year of Treatment When half of the patients in our study complete one year of treatment, a comprehensive analysis will be conducted to assess the effectiveness of the main treatment. This means that the results will be considered when data from 105 patients have been collected (35 in each group).
The Bayesian inference statistical technique will be used to combine and adapt the data collected during the treatment monitoring period.
Adaptive Approach
The study has been designed adaptively, which means that it can be adjusted based on the intermediate results emerging during the research. The central advantage of the adaptive design is the ability to include prospectively planned opportunities for modifying study design elements and hypotheses based upon interim data analyses. Bayesian statistics provide a method for updating information about the treatment effect as new data are observed and hence are well suited to interim analyses with accumulating efficacy data. Early stopping for statistical futility is useful in this trial as it can preserve resources that could instead be used on more promising active arms and prevent patients from being given an ineffective experimental treatment dosage. After one year of treatment, for half of the participants there are several scenarios that may occur:
- If there are 8 or fewer people who respond positively in each group of patients who have received the active treatment (the treatment with medication), there should be the discontinuation of that treatment group as it is deemed ineffective.
- If there are 27 or more patients who respond positively in both active treatment groups, there should be the discontinuation of the placebo treatment group, as it is confirmed that the active treatment is working well.
- If there is a significant difference in treatment response between the active groups but the necessary number of patients to discontinue the placebo treatment arm is not reached, it could be hypothesized that the active treatment is advantageous, and the sample size of patients should be reassessed to confirm this hypothesis.
After the End of Study visit, no Follow-Up visits are foreseen. The following assessments will be performed throughout the conduction of study: Refraction test for measuring visual acuity (VA) (near and distance); Pupil diameter (PD) in photopic lighting conditions; Accommodation amplitude; Intraocular Pressure Measurement; Stereopsis; Slit lamp examination; Macular/optic disc examination by age appropriate methods (e.g. fundoscopy, or fundus photo); Ocular biometry; Instillation of cycloplegic agents, different participating site will follow their standard cycloplegic regimen (1% Tropicamide and 1% cyclopentolate eye drop); Cycloplegic autorefraction (to evaluate the refractive power of the eye); Measurement of prescription in current glasses (focimetry); Urine pregnancy test; Adverse event (AE)/Serious Adverse Event (SAE) assessments; Questionnaires (Student Refractive Error and Eyeglasses Questionnaire - Revised (SREEQ-R), Visual Light Sensitivity Questionnaire-8 (VLSQ-8), 3-items questionnaire for acceptability of the formulation) will be used.
- Conditions
- Myopia
- Being tested
- 0.05% atropine eye drops, 0.025% atropine eye drops, placebo eye drops
- Keywords
- Myopia, Atropine sulfate, Eye drops, Short-sightedness, Eye Diseases, Paediatric population
- Medical subject headings
- Myopia, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% atropine eye dropsDrug
Also called atropine sulfate eye drops solutions (0.05%)
One drop of 0.05% atropine in each eye once a day before bedtime
0.025% atropine eye dropsDrug
Also called atropine sulfate eye drops solutions (0.025%)
One drop of 0.025% atropine in each eye once a day before bedtime
placebo eye dropsDrug
Also called Control
One drop of placebo in each eye once a day before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | This group (N = 78 subjects) will be treated with 0.05% atropine eye drops Receives: Drug: 0.05% atropine eye drops |
| Group 2 | Experimental | This group (N = 78 subjects) will be treated with 0.025% atropine eye drops Receives: Drug: 0.025% atropine eye drops |
| Group 3 | Placebo comparator | This group (N = 78 subjects) will be treated with placebo eye drops Receives: Drug: placebo eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean annual rate of progression of myopia
The primary outcome measure evaluates the efficacy of atropine in slowing myopia progression in children and adolescents. The mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction over 24 months.
Measured: 24 months
Secondary outcomes (12)
Number and percentage of early escape patients.
To assess the early escape rate in the placebo group. Patients who show significant myopia progression at the 6-month mark will be switched to atropine eye drops at the investigator's discretion.
Measured: 6 months
Mean change in axial length and glasses prescription.
Assessment of the mean change in axial length (mm) and glasses prescription over a longer period of time to investigate the efficacy of the intervention.
Measured: 3, 6, 12, 18 and 24 months
Safety assessment of atropine.
Evaluation of safety by measuring the counts and percentage of patients reporting any adverse events.
Measured: 3, 6, 12, 18 and 24 months
Use of photochromic and/or varifocal lenses.
Number and percentage of participants requiring the use of photochromic and/or varifocal lenses.
Measured: 3, 6, 12, 18, and 24 months
Changes in photosensitivity index.
Evaluation of changes in photosensitivity index, used to monitor treatment-induced light sensitivity over time.
Measured: Baseline, 3, 6, 12, 18, and 24 months
Best Corrected Visual Acuity.
Assessment of best corrected distance and near visual acuity using standardised methods appropriate for participant age.
Measured: 3, 6, 12, 18, and 24 months
Pupil Diameter (PD) in photopic lighting condition.
Measurement of PD (in mm) under photopic and average lighting using a PD ruler or autorefractor.
Measured: 3, 6, 12, 18, and 24 months
Accommodation amplitude.
Measurement of the accommodation amplitude (diopter) performed monocularly and binocularly over distance correction.
Measured: 3, 6, 12, 18, and 24 months
Vision-related quality of life (SREEQ-R).
Patient-reported assessment of vision-related quality of life using validated questionnaire (Student Refractive Error and Eyeglasses Questionnaire - Revised - SREEQ-R) at specified time points.
Measured: Baseline, 6, 12 and 24 months
Vision-related quality of life (VLSQ-8).
Patient-reported assessment of vision-related quality of life using validated questionnaire (Self-reported, Visual Light Sensitivity Questionnaire-8 - VLSQ-8) at specified time points.
Measured: Baseline, 6, 12 and 24 months
Acceptability of atropine formulation.
Assessment of acceptability of the formulation using a 3-item questionnaire, scored on a six-point scale. The questionnaire consists of a survey investigating ocular symptoms and discomforts after eye drops instillation.
Measured: 3, 6, 12, 18 and 24 months
Overall between-group difference from baseline in the proportion of subjects who show < -0.50 D myopia progression (Spherical Equivalent Refraction, SER).
Comparison of the proportion of subjects in each treatment group who show myopia progression (SER) of less than -0.50 D at 24 months. Statistical analysis will include a Chi-square test or Fisher's exact test to evaluate between-group differences.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design includes 2 active arms (Atropine 0.025% or 0.05%) and a placebo arm. The study has a 2 stages seamless adaptive design (before/after interim analysis results). After the interim analysis, when half of the planned sample size is enrolled and the 1-year efficacy evaluation is available, the use of an adaptive trial design will be deemed: * each active arm will be stopped for futility if there are 8 patients or fewer (≤ 22.9%) with response (reduction in mean SE progression of at least 20% when compared with the placebo group; * the placebo arm will be stopped early for evidence of efficacy if there are 27 patients or more (≥ 77.1%) with response (reduction in mean SE progression of at least 20% when compared with the placebo group) in both active arms. Instead, if active arms show a favorable SE change but fewer than 27 responders in 1 or both active arms, an advantage for atropine can be hypothesized, allowing for sample size re-estimation to ensure adequate study power
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocus Innovation Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Euromed Pharma Services SRL, Consorzio per Valutazioni Biologiche e Farmacologiche
- Responsible party
- Sponsor
- Investigators
- Ian CK Wong, Professor, Principal investigator, Ocus Innovation Ireland LimitedAnnegret Dahlmann-Noor, PhD, Study chair, NIHR Moorfields Biomedical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028827
- Sponsor's protocol ID
- OCUS-Mode-CT-V1
- Other IDs
- 2023-510439-13-00, 1009562, U1111-1304-3811, 2023
- Acronym
- MODERATO
- Status last verified
- Feb 2026
- First submitted
- 23 May 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Multiple Doses, Placebo-controlled, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Atropine for the Treatment of Myopia Progression in Children and Adolescents (MODERATO Study)
- ClinicalTrials.gov ID
- NCT07028827
- Acronym / sponsor ID
- MODERATO / OCUS-Mode-CT-V1
- Conditions
- Myopia
- Keywords
- Myopia, Atropine sulfate, Eye drops, Short-sightedness, Eye Diseases, Paediatric population
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Ocus Innovation Ireland LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Euromed Pharma Services SRL, Consorzio per Valutazioni Biologiche e Farmacologiche
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Jun 2025 (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, or shortsightedness, is a multifactorial disorder, governed by environmental and genetic factors.
Myopia is the most common ocular disorder worldwide with an increasing prevalence over the past few decades and affecting the quality of life and economic health of individuals worsening socio-economic problems.
Progressive myopia is nearly exclusively a condition of childhood and adolescence, as in most young adults, myopia has stabilized.
Myopia frequently appears in childhood, with a peak incidence occurring between 8 and 10 years of age.
The most used topical pharmacological intervention for managing childhood myopia progression is atropine, a non-selective muscarinic antagonist, which has been widely used in clinical trials in concentrations ranging from 0.01% to 1.0%.
Atropine is at present the agent with the highest efficacy and optimal safety profile to reduce myopia progression in children and adolescents.
MODERATO study, a phase III, prospective, multicentric, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study, aims to evaluate the efficacy and safety of 0.025% and 0.05% atropine eye drops in children and adolescents aged 3 to under 18 years old over a 24-month period, to understand its ability to manage and stop myopia getting worse. It will be conducted in 11 centers in Italy, Spain, Poland, the UK and Albania.
Detailed description
The MODERATO study is a phase III, prospective, multicentric, randomized, double-blind, parallel group, adaptive, placebo-controlled trial. The study will be conducted in primary care and hospital settings in 3 European countries (Italy, Spain, Poland), in the UK and in Albania, involving a total of 11 centers.
The study hypothesis is that low dose (0.025% and 0.05%) of atropine eye drops will reduce the myopia progression in children and adolescents (3-18 years of age) compared with placebo eye drops, over 24 months.
A total of 234 participants from 5 countries will be estimated to take part in the study.
Eligible participants with myopia with a spherical equivalent refraction of both eyes at least -0.75 D at baseline will be randomized to treatment (0.025% atropine eye drops, 0.05% atropine eye drops) and placebo groups in 1:1:1 ratio. Each arm will consist of at least 78 individuals.
In this study, the primary objective is to evaluate efficacy of 0.025% and 0.05% atropine eye drops in children and adolescents over 24 months to slow the progression of myopia.
A formal interim efficacy analysis on the primary endpoint will be planned when the 50% of the total planned sample size has completed the 1-year treatment follow-up (105 evaluable patients in total: 35 in each arm).
"EARLY ESCAPE" Phase of Patients after Six Months of Atropine Eye Drops Treatment At the sixth month of treatment, if the patients who received the placebo treatment show worsening of their myopia, they will be switched to the active treatment. This approach is called "early escape", which ensures that the patients receive the best treatment as soon as possible, reducing the time during which they may receive ineffective treatment. The analysis will be conducted by a team of experts, Data Safety Monitoring Committee (DSMC). The treatment after the early escape will be carried out as open label study. Blinding will be maintained for the patients who do not early escape.
Analysis after One Year of Treatment When half of the patients in our study complete one year of treatment, a comprehensive analysis will be conducted to assess the effectiveness of the main treatment. This means that the results will be considered when data from 105 patients have been collected (35 in each group).
The Bayesian inference statistical technique will be used to combine and adapt the data collected during the treatment monitoring period.
Adaptive Approach
The study has been designed adaptively, which means that it can be adjusted based on the intermediate results emerging during the research. The central advantage of the adaptive design is the ability to include prospectively planned opportunities for modifying study design elements and hypotheses based upon interim data analyses. Bayesian statistics provide a method for updating information about the treatment effect as new data are observed and hence are well suited to interim analyses with accumulating efficacy data. Early stopping for statistical futility is useful in this trial as it can preserve resources that could instead be used on more promising active arms and prevent patients from being given an ineffective experimental treatment dosage. After one year of treatment, for half of the participants there are several scenarios that may occur:
- If there are 8 or fewer people who respond positively in each group of patients who have received the active treatment (the treatment with medication), there should be the discontinuation of that treatment group as it is deemed ineffective.
- If there are 27 or more patients who respond positively in both active treatment groups, there should be the discontinuation of the placebo treatment group, as it is confirmed that the active treatment is working well.
- If there is a significant difference in treatment response between the active groups but the necessary number of patients to discontinue the placebo treatment arm is not reached, it could be hypothesized that the active treatment is advantageous, and the sample size of patients should be reassessed to confirm this hypothesis.
After the End of Study visit, no Follow-Up visits are foreseen. The following assessments will be performed throughout the conduction of study: Refraction test for measuring visual acuity (VA) (near and distance); Pupil diameter (PD) in photopic lighting conditions; Accommodation amplitude; Intraocular Pressure Measurement; Stereopsis; Slit lamp examination; Macular/optic disc examination by age appropriate methods (e.g. fundoscopy, or fundus photo); Ocular biometry; Instillation of cycloplegic agents, different participating site will follow their standard cycloplegic regimen (1% Tropicamide and 1% cyclopentolate eye drop); Cycloplegic autorefraction (to evaluate the refractive power of the eye); Measurement of prescription in current glasses (focimetry); Urine pregnancy test; Adverse event (AE)/Serious Adverse Event (SAE) assessments; Questionnaires (Student Refractive Error and Eyeglasses Questionnaire - Revised (SREEQ-R), Visual Light Sensitivity Questionnaire-8 (VLSQ-8), 3-items questionnaire for acceptability of the formulation) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study design includes 2 active arms (Atropine 0.025% or 0.05%) and a placebo arm. The study has a 2 stages seamless adaptive design (before/after interim analysis results). After the interim analysis, when half of the planned sample size is enrolled and the 1-year efficacy evaluation is available, the use of an adaptive trial design will be deemed: * each active arm will be stopped for futility if there are 8 patients or fewer (≤ 22.9%) with response (reduction in mean SE progression of at least 20% when compared with the placebo group; * the placebo arm will be stopped early for evidence of efficacy if there are 27 patients or more (≥ 77.1%) with response (reduction in mean SE progression of at least 20% when compared with the placebo group) in both active arms. Instead, if active arms show a favorable SE change but fewer than 27 responders in 1 or both active arms, an advantage for atropine can be hypothesized, allowing for sample size re-estimation to ensure adequate study power
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: 0.05% atropine eye dropsThis group (N = 78 subjects) will be treated with 0.05% atropine eye drops |
| Group 2 | Experimental | Drug: 0.025% atropine eye dropsThis group (N = 78 subjects) will be treated with 0.025% atropine eye drops |
| Group 3 | Placebo comparator | Drug: placebo eye dropsThis group (N = 78 subjects) will be treated with placebo eye drops |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Males and females, aged from 3 to less than 18 years.
- Subjects showing myopia with a spherical equivalent refraction of both eyes at least -0.75 D at baseline.
- The intraocular pressure in each eye must be equal or less than 21 mmHg.
- The parents or the legal representative must be informed about the clinical trial and must sign the informed consent form. The exception to consider is related to the individuals aged above 16 years only in the UK, who can provide their own consent according to the local regulations.
- Women with childbearing potential (WOCBP) (after menarche) who have a negative highly sensitive urine dipstick pregnancy test. Additional pregnancy testing during the study will be conducted at visits 1, 2, 3, 4, 5, 6.
Key exclusion criteria (16 listed)
- Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding |1.5| D.
- Refractive astigmatism exceeding |1.5| D.
- Presence of ocular pathologies such as pathological myopia, corneal scars, or other anterior or posterior eye pathologies.
- History of amblyopia or strabismus.
- Presence of a history of a retinal dystrophy or systemic disorder that may predispose to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity)
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 |
|---|---|---|
| 0.05% atropine eye dropsAlso: atropine sulfate eye drops solutions (0.05%)One drop of 0.05% atropine in each eye once a day before bedtime | Drug | Group 1 |
| 0.025% atropine eye dropsAlso: atropine sulfate eye drops solutions (0.025%)One drop of 0.025% atropine in each eye once a day before bedtime | Drug | Group 2 |
| placebo eye dropsAlso: ControlOne drop of placebo in each eye once a day before bedtime | Drug | Group 3 |
Primary outcome
Mean annual rate of progression of myopia
Time frame: 24 months
The primary outcome measure evaluates the efficacy of atropine in slowing myopia progression in children and adolescents. The mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction over 24 months.
12 secondary outcomes
Number and percentage of early escape patients.
Time frame: 6 months
Mean change in axial length and glasses prescription.
Time frame: 3, 6, 12, 18 and 24 months
Safety assessment of atropine.
Time frame: 3, 6, 12, 18 and 24 months
Use of photochromic and/or varifocal lenses.
Time frame: 3, 6, 12, 18, and 24 months
Changes in photosensitivity index.
Time frame: Baseline, 3, 6, 12, 18, and 24 months
Best Corrected Visual Acuity.
Time frame: 3, 6, 12, 18, and 24 months
Pupil Diameter (PD) in photopic lighting condition.
Time frame: 3, 6, 12, 18, and 24 months
Accommodation amplitude.
Time frame: 3, 6, 12, 18, and 24 months
Vision-related quality of life (SREEQ-R).
Time frame: Baseline, 6, 12 and 24 months
Vision-related quality of life (VLSQ-8).
Time frame: Baseline, 6, 12 and 24 months
Acceptability of atropine formulation.
Time frame: 3, 6, 12, 18 and 24 months
Overall between-group difference from baseline in the proportion of subjects who show < -0.50 D myopia progression (Spherical Equivalent Refraction, SER).
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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.
Ian CK Wong, Professor principal investigator
Ocus Innovation Ireland Limited
Annegret Dahlmann-Noor, PhD study chair
NIHR Moorfields Biomedical Research Centre
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.05% atropine eye drops and 0.025% atropine eye drops in people with Myopia, run by Ocus Innovation Ireland Limited at 11 sites in 5 countries.
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 6 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy, Spain, United Kingdom, Albania, Poland. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irisi Sukaj (+355 68 90 37 854, isukaj@cvbf.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean annual rate of progression of myopia (time frame: 24 months). 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 11 Feb 2026.