Condition: Myopia · Sponsor: Ocus Innovation Ireland Limited
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.
This description comes directly from the study's public registry record.
Irisi Sukaj · +355 68 90 37 854 · isukaj@cvbf.net
Alessandra Foietta · +39 0382 1475411 · afoietta@cvbf.net
Always discuss trial participation with your own doctor first.
| University Hospital Centre Mother Teresa (UHCT), Paediatric Department | Tirana, Albania | Recruiting |
| Ophthalmology - AOU Consorziale Policlinico - Ospedale Pediatrico Giovanni XXIII | Bari, Italy | Recruiting |
| Pediatric Ophthalmology - Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Milan | Milan, Italy | Recruiting |
| Azienda Ospedale Università Padova | Padua, Italy | Not Yet Recruiting |
| Children's Memorial Health Institute, Department of Ophthalmology | Warsaw, Poland | Recruiting |
| Hospital Universitario Parc Taulí | Barcelona, Spain | Recruiting |
| Hospital Puerta del Mar (INIBICA) | Cadiz, Spain | Recruiting |
| Hospital Universitario La Paz | Madrid, Spain | Recruiting |
| Northern Ireland Clinical Research Facility. U Floor. Belfast City Hospital | Belfast, United Kingdom | Recruiting |
| School of Optometry, Aston University | Birmingham, United Kingdom | Recruiting |
| R&D, Moorfields Eye Hospital | London, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07028827