Health Trials

Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)

ConditionMyopia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-17
SponsorOcus Innovation Ireland Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.05% atropine eye drops

    Drug

    One drop of 0.05% atropine in each eye once a day before bedtime

  • 0.025% atropine eye drops

    Drug

    One drop of 0.025% atropine in each eye once a day before bedtime

  • placebo eye drops

    Drug

    One drop of placebo in each eye once a day before bedtime

Treatment groups

234 Participants
are divided into 3 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ocus Innovation Ireland Limited

Lead sponsor

Euromed Pharma Services SRL

Collaborator

Consorzio per Valutazioni Biologiche e Farmacologiche

Collaborator

Source ClinicalTrials.gov
Apply now