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

Sponsor
Ocus Innovation Ireland Limited
Study ID
NCT07028827
Phase
PHASE3
Status
Recruiting
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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Jun 19, 2025
Start date
Sep 1, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
234 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    This group (N = 78 subjects) will be treated with 0.05% atropine eye drops
  • Experimental: Group 2
    This group (N = 78 subjects) will be treated with 0.025% atropine eye drops
  • Placebo Comparator: Group 3
    This group (N = 78 subjects) will be treated with placebo eye drops

Primary Outcome Measure

Mean annual rate of progression of myopia [ Time Frame: 24 months ]

Central Contacts

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