A Phase 3 interventional study of 0.05% atropine eye drops and 0.025% atropine eye drops in Myopia, sponsored by Ocus Innovation Ireland Limited. Recruiting at 11 sites in 5 countries. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Ocus Innovation Ireland Limited · Phase 3, Interventional, and Treatment
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.
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:
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 234 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →This is the only study on the registry with Ocus Innovation Ireland Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group (N = 78 subjects) will be treated with 0.05% atropine eye drops
Drug: 0.05% atropine eye drops
This group (N = 78 subjects) will be treated with 0.025% atropine eye drops
Drug: 0.025% atropine eye drops
This group (N = 78 subjects) will be treated with placebo eye drops
Drug: placebo eye drops
One drop of 0.05% atropine in each eye once a day before bedtime
Also known as: atropine sulfate eye drops solutions (0.05%)
One drop of 0.025% atropine in each eye once a day before bedtime
Also known as: atropine sulfate eye drops solutions (0.025%)
One drop of placebo in each eye once a day before bedtime
Also known as: Control
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.
Time frame: 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3, 6, 12, 18, and 24 months
Accommodation amplitude.
Measurement of the accommodation amplitude (diopter) performed monocularly and binocularly over distance correction.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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).
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.
Time frame: 24 months
Plan to share: No
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Started Sep 2025 (actual). Primary completion is estimated for Dec 2027, 27 months after the start.
Of 25 phase 3 interventional studies under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Atropine