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Clinical Trials in Ireland / NCT03690089
Active, not recruiting Phase 2

Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom

NCT03690089 · tracked via the Priya Life Science Ireland tracker
Sponsor
Belfast Health and Social Care Trust
Phase
Phase 2
Started
2019-04-03
Last updated
2023-09-07

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

Atropine SulfatePlacebo

Atropine Sulfate: Atropine sulfate 0.01% eye drops which consist of 10mls of a clear colourless solution of atropine sulfate 0.01% w/v and benzalkonium chloride 0.01% w/v in sterile water.

Placebo: Placebo eye drops which consist of 10mls of a clear colourless solution of benzalkonium chloride 0.01% w/v in sterile water.

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Northern Ireland Clinical Research Belfast United Kingdom
Aston University Eye Clinic Birmingham United Kingdom
Anglia Ruskin University Eye Clinic Cambridge United Kingdom
Centre for Living (Glasgow Caledonian University) Glasgow United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03690089 on ClinicalTrials.gov ↗ ← All trials in Ireland