Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children: a Multi-centre Placebo Controlled Randomised Trial in the United Kingdom

17097AB-AS

Short-sightedness, also called myopia, makes objects in the distance, such as the television, look blurred. This is caused by the eye growing too long, something that usually happens while children are also getting taller. People with myopia can see better with glasses or contact lenses, but this doesn't stop their eyes continuing to become more short-sighted. The CHAMP UK study is investigating a type of eye drop called atropine that might help to stop myopia getting worse as children get older.

2019-04-03

2024-02-29

2027-02-02

Active (not recruiting)

Early phase I

289

Inclusion Criteria: 1. Age 6-12 years (at the time of consenting) 2. Myopia of -0.5D or greater (spherical equivalent refractive error) in both eyes 3. Best-corrected distance visual acuity (BCDVA) 0.20 logMAR or better in both eyes Exclusion Criteria: 1. Children with other ocular morbidities 2. Myopia of -10D or greater in either eye 3. Astigmatism of 2D or higher in either eye 4. Amblyopia 5. Significant health problems that can compromise the ability to attend research visits or complete the trial 6. Other factors that may compromise the ability to attend the research appointments 7. Parents or children with poor understanding of the English language 8. Children enrolled in other interventional trials 9. Allergy or hypersensitivity to atropine or excipients

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre, randomised, double-masked, placebo-controlled superiority trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-masked', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 289, 'type': 'ESTIMATED'}}

2023-09-07