MODERATO Study
Research type
Research Study
Full title
A phase III, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study to evaluate the efficacy of atropine to treat the progression of myopia in children and adolescents from 3 to less than 18 years of age
IRAS ID
1009562
Contact name
Vanessa Ng
Contact email
Sponsor organisation
OCUS Innovation Ireland Limited
ISRCTN Number
Not yet registered
Clinicaltrials.gov Identifier
Not yet registered
Research summary
This is a multi-national, randomized, double-blinded and placebo- controlled study to evaluate the efficacy of atropine eyedrops in children and adolescents from 3 to less than 18 years of age who suffer from shortsightedness (myopia). This trial aims to evaluate if atropine eyedrops may reduce the progression of myopia. Over 200 participants will be recruited across 11 sites in UK, Europe and Albania. Patients will be approached to participate in the study and only those over 16 years old or those aged under 16 whose parents have provided written informed consent and meet the eligibility criteria will be treated for 2 years. Children will be assigned into 3 groups by chance (randomized): two active groups will be treated with 0.025% or 0.05% atropine eyedrops and one group will be treated with placebo (identical looking eye drops solution but with no medicine in them); both patients and research study team will be blinded, which means they won't know what treatment they are taking. During the study, the patients will have various eye examinations and tests performed over the course of six visits. All these tests are routine and non-invasive, designed to assess the children’ vision and eye health. After the first year of eye drops treatment, an interim analysis will help to understand whether atropine treatment is effective and both active groups and placebo group can continue or can be stopped.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0272
Date of REC Opinion
24 Feb 2025
REC opinion
Further Information Favourable Opinion