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

NCT03690089 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 17097AB-AS2017-004108-23
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Spherical equivalent refractive error (i.e. myopia severity)

  Spherical equivalent refractive error (i.e., myopia severity) of both eyes measured by autorefractor under cycloplegia (adjusted for baseline).

  Baseline - 24-months

Secondary Outcomes (10)

• Central axial length

  Baseline - 24-months

• Best corrected distance visual acuity (BCdVA) (uniocular and binocular)

  Baseline - 24-months

• Near visual acuity (uniocular and binocular)

  Baseline - 24-months

• Reading speed

  Baseline - 24-months

• Pupil diameter

  Baseline - 24-months

Other Outcomes (8)

• Peripheral axial length

  Baseline - 24-months

• Peripheral retinal defocus

  Baseline - 24-months

• Anterior chamber depth

  Baseline - 24-months

Study Arms (2)

Intervention Group (Atropine 0.01%)

EXPERIMENTAL

The intervention group will receive 0.01% atropine sulfate eye drops, administered once daily for two years.

Drug: Atropine Sulfate

Placebo Group

PLACEBO COMPARATOR

The control group will receive placebo eye drops, administered once daily for two years.

Other: Placebo

Interventions

Atropine Sulfate DRUG

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.

Intervention Group (Atropine 0.01%)

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-12 years (at the time of consenting)
• Myopia of -0.5D or greater (spherical equivalent refractive error) in both eyes
• Best-corrected distance visual acuity (BCDVA) 0.20 logMAR or better in both eyes

You may not qualify if:

• Children with other ocular morbidities
• Myopia of -10D or greater in either eye
• Astigmatism of 2D or higher in either eye
• Amblyopia
• Significant health problems that can compromise the ability to attend research visits or complete the trial
• Other factors that may compromise the ability to attend the research appointments
• Parents or children with poor understanding of the English language
• Children enrolled in other interventional trials
• Allergy or hypersensitivity to atropine or excipients

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead

Study Sites (4)

Northern Ireland Clinical Research

Belfast, BT9 7AB, United Kingdom

Location

Aston University Eye Clinic

Birmingham, B4 7ET, United Kingdom

Location

Anglia Ruskin University Eye Clinic

Cambridge, CB1 1PT, United Kingdom

Location

Centre for Living (Glasgow Caledonian University)

Glasgow, G4 0BA, United Kingdom

Location

Related Publications (1)

• Azuara-Blanco A, Logan N, Strang N, Saunders K, Allen PM, Weir R, Doherty P, Adams C, Gardner E, Hogg R, McFarland M, Preston J, Verghis R, Loughman JJ, Flitcroft I, Mackey DA, Lee SS, Hammond C, Congdon N, Clarke M. Low-dose (0.01%) atropine eye-drops to reduce progression of myopia in children: a multicentre placebo-controlled randomised trial in the UK (CHAMP-UK)-study protocol. Br J Ophthalmol. 2020 Jul;104(7):950-955. doi: 10.1136/bjophthalmol-2019-314819. Epub 2019 Oct 25.

  PMID: 31653669 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Augusto Azuara-Blanco, PhD FRCOphth

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, randomised, double-masked, placebo-controlled superiority trial

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: October 1, 2018
• Study Start: April 3, 2019
• Primary Completion: February 29, 2024
• Study Completion (Estimated): February 2, 2027
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

GB (4)