Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom (CHAMP-UK)
Primary Purpose
Myopia
Status
Active
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Atropine Sulfate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Northern Ireland Clinical Research
- Aston University Eye Clinic
- Anglia Ruskin University Eye Clinic
- Centre for Living (Glasgow Caledonian University)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group (Atropine 0.01%)
Placebo Group
Arm Description
The intervention group will receive 0.01% atropine sulfate eye drops, administered once daily for two years.
The control group will receive placebo eye drops, administered once daily for two years.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Central axial length
Measured using a laser biometer at central fixation conditions.
Best corrected distance visual acuity (BCdVA) (uniocular and binocular)
Assessed using the logMAR ETDRS chart. This is a standard letter chart used in research to ensure accuracy and validity of the acuity measurements and has been shown to be repeatable in children.
Near visual acuity (uniocular and binocular)
Tested using near logMAR ETDRS at 40 cm.
Reading speed
Measured with the Wilkins Rate of Reading test.
Pupil diameter
Measured using an autorefractor.
Accommodation
Measured prior to the instillation of cycloplegia using the autorefractor. The measures will be taken monocularly in each eye and binocularly (minimum 3 measurements per condition). The accommodation response (accommodation lag) will be determined by calculating the difference between the Accommodation Response (AR = near MSE (autorefractor)) and the Accommodation Stimulus.
Spectacle correction
Current spectacle prescription.
Eye drop tolerability
Assessed using a 4-point scale to quantify, from the point of view of the participant, (1) local irritation/stinging associated with eye drop instillation; (2) photophobia; and (3) difficulties reading and writing.
Adverse event rates and allergic reactions rates
All AEs will be assessed for seriousness, causality, severity and if the adverse event is related to the study drug, for expectedness.
Quality of Life: measured using the EQ-5D-Y
The EQ-5D-Y evaluates five dimensions of a child's health (mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy) using three levels (no problems, some problems and a lot of problems). Each response results in a one-digit number, which can be tallied up for the five dimensions. Participants will then indicate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (best health you can imagine).
Full Information
NCT ID
NCT03690089
First Posted
August 20, 2018
Last Updated
September 6, 2023
Sponsor
Belfast Health and Social Care Trust
1. Study Identification
Unique Protocol Identification Number
NCT03690089
Brief Title
Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom
Acronym
CHAMP-UK
Official Title
Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children: a Multi-centre Placebo Controlled Randomised Trial in the United Kingdom
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belfast Health and Social Care Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study hypothesis is that low dose atropine eye drops will reduce the progression of short-sightedness in children compared with placebo eye drops. This is a randomised controlled trial which will be conducted across four Clinical Research Facilities associated with higher education institutions in the UK. It is a double masked trial, that is, neither the participant or the research team will know what treatment the participants are receiving. 289 children aged 6-12 years with short-sightedness will be recruited to the trial. They will be randomly chosen to receive either atropine eye drops or placebo eye drops on a 2:1 basis. Therefore, 193 participants will receive atropine eye drops, 96 participants will receive placebo eye drops.
Potential participants will be referred either by their high street optician or their parents will refer them directly. The study will be advertised on local radio. Potential participants will be invited to attend a baseline screening visit. Written informed consent and written informed assent will be obtained from the parent and child prior to undertaking any assessments. Potential participants will undergo a number of assessments similar to what is conducted by the high street optician or eye clinic to determine if they are eligible to participate. These include: assessment of near and distance vision, reading speed and different measurements of the eye using instruments. An eye drop will be put into each eye for some of these assessments. These drops cause a short-term increase in pupil size, which may last for 12-24 hours, and make close up vision (through their glasses) blurry for up to four hours, and may make them more sensitive to bright light. Participants will also be asked about their quality of life and their daily activities such as screen time, playing outside and reading.
Participants will be instructed in the use of the eye drops. They will put one drop in each eye daily for 24 months. The atropine eye drops contain 0.01% atropine sulphate. Placebo eye drops have been chosen as the comparator group as there is no alternative treatment for this condition. Participants will be given a six month supply of eye drops at each visit (except the last visit at 24 months). This will include seven bottles as each bottle can only be used for 28 days after opening.
Participants will have a further four visits to the research facility for the assessments to be repeated. This will be every six months, therefore five visits in total (baseline, 6 months, 12 months, 18 months and 24 months). It is anticipated that each visit will last approximately 1-2 hours. Children will be offered the opportunity to rest between assessments. At these follow up visits, in addition to the assessments, they will be asked about their tolerability of the eye drops. Also, five years after randomisation, the investigators will post a questionnaire to participants and ask details of any possible complications and adverse events. The investigators will also request information from their optometrist regarding their eye health, distance vision and refractive error data.
The primary outcome is the change in the severity of short-sightedness after 24 months. This will be measured using a machine called an autorefractor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multicentre, randomised, double-masked, placebo-controlled superiority trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-masked
Allocation
Randomized
Enrollment
289 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group (Atropine 0.01%)
Arm Type
Experimental
Arm Description
The intervention group will receive 0.01% atropine sulfate eye drops, administered once daily for two years.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
The control group will receive placebo eye drops, administered once daily for two years.
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate
Intervention Description
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 Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo eye drops which consist of 10mls of a clear colourless solution of benzalkonium chloride 0.01% w/v in sterile water.
Primary Outcome Measure Information:
Title
Spherical equivalent refractive error (i.e. myopia severity)
Description
Spherical equivalent refractive error (i.e., myopia severity) of both eyes measured by autorefractor under cycloplegia (adjusted for baseline).
Time Frame
Baseline - 24-months
Secondary Outcome Measure Information:
Title
Central axial length
Description
Measured using a laser biometer at central fixation conditions.
Time Frame
Baseline - 24-months
Title
Best corrected distance visual acuity (BCdVA) (uniocular and binocular)
Description
Assessed using the logMAR ETDRS chart. This is a standard letter chart used in research to ensure accuracy and validity of the acuity measurements and has been shown to be repeatable in children.
Time Frame
Baseline - 24-months
Title
Near visual acuity (uniocular and binocular)
Description
Tested using near logMAR ETDRS at 40 cm.
Time Frame
Baseline - 24-months
Title
Reading speed
Description
Measured with the Wilkins Rate of Reading test.
Time Frame
Baseline - 24-months
Title
Pupil diameter
Description
Measured using an autorefractor.
Time Frame
Baseline - 24-months
Title
Accommodation
Description
Measured prior to the instillation of cycloplegia using the autorefractor. The measures will be taken monocularly in each eye and binocularly (minimum 3 measurements per condition). The accommodation response (accommodation lag) will be determined by calculating the difference between the Accommodation Response (AR = near MSE (autorefractor)) and the Accommodation Stimulus.
Time Frame
Baseline - 24-months
Title
Spectacle correction
Description
Current spectacle prescription.
Time Frame
Baseline - 24-months
Title
Eye drop tolerability
Description
Assessed using a 4-point scale to quantify, from the point of view of the participant, (1) local irritation/stinging associated with eye drop instillation; (2) photophobia; and (3) difficulties reading and writing.
Time Frame
Baseline - 24-months
Title
Adverse event rates and allergic reactions rates
Description
All AEs will be assessed for seriousness, causality, severity and if the adverse event is related to the study drug, for expectedness.
Time Frame
Baseline - 24-months
Title
Quality of Life: measured using the EQ-5D-Y
Description
The EQ-5D-Y evaluates five dimensions of a child's health (mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy) using three levels (no problems, some problems and a lot of problems). Each response results in a one-digit number, which can be tallied up for the five dimensions. Participants will then indicate their overall health on a visual analogue scale from 0 (worst health you can imagine) to 100 (best health you can imagine).
Time Frame
Baseline - 24-months
Other Pre-specified Outcome Measures:
Title
Peripheral axial length
Description
Measured using a laser biometer at peripheral fixation conditions
Time Frame
Baseline - 24-months
Title
Peripheral retinal defocus
Description
Measured with the autorefractor at central and peripheral fixation conditions.
Time Frame
Baseline - 24-months
Title
Anterior chamber depth
Description
Measured with a laser biometer.
Time Frame
Baseline - 24-months
Title
Iris colour
Description
Measured using a visual grading scale of dark brown, light brown, blue, green, grey.
Time Frame
Baseline - 24-months
Title
Height in cms
Description
To provide information about the links between the child's development and eye growth and potentially information about lifestyle.
Time Frame
Baseline - 24-months
Title
Weight in kgs
Description
To provide information about the links between the child's development and eye growth and potentially information about lifestyle.
Time Frame
Baseline - 24-months
Title
Hours of outdoor activity
Description
Measured using an activities questionnaire.
Time Frame
Baseline - 24-months
Title
Ciliary body biometry
Description
Measured using anterior-segment OCT (AS-OCT). This will enable changes in lens position and ciliary muscle changes resulting from atropine use to be compared with normal myopic growthChorio-retinal thickness: measured using spectral domain OCT (SR-OCT). This will enable differences in choroidal thickness resulting from atropine use to be compared with normal myopic growth.
Time Frame
Baseline - 24-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Augusto Azuara-Blanco, PhD FRCOphth
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Ireland Clinical Research
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Aston University Eye Clinic
City
Birmingham
ZIP/Postal Code
B4 7ET
Country
United Kingdom
Facility Name
Anglia Ruskin University Eye Clinic
City
Cambridge
ZIP/Postal Code
CB1 1PT
Country
United Kingdom
Facility Name
Centre for Living (Glasgow Caledonian University)
City
Glasgow
ZIP/Postal Code
G4 0BA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31653669
Citation
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.
Results Reference
derived
Learn more about this trial
Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom
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