MyopiaPhase 2CHAMP-UKNCT03690089
Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom
A Phase 2 study testing Atropine Sulfate in people with Myopia, run by Belfast Health and Social Care Trust at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 3 Apr 2019to 2 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Parents or children with poor understanding of the English language
- Children enrolled in other interventional trials
- Allergy or hypersensitivity to atropine or excipients
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Northern Ireland Clinical Research
Belfast, BT9 7AB
Aston University Eye Clinic
Birmingham, B4 7ET
Anglia Ruskin University Eye Clinic
Cambridge, CB1 1PT
Centre for Living (Glasgow Caledonian University)
Glasgow, G4 0BA
About this study
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
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- Atropine Sulfate, Placebo
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine SulfateDrug
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.
PlaceboOther
Placebo eye drops which consist of 10mls of a clear colourless solution of benzalkonium chloride 0.01% w/v in sterile water.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Atropine 0.01%) | Experimental | The intervention group will receive 0.01% atropine sulfate eye drops, administered once daily for two years. Receives: Drug: Atropine Sulfate |
| Placebo Group | Placebo comparator | The control group will receive placebo eye drops, administered once daily for two years. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline - 24-months
Secondary outcomes (10)
Central axial length
Measured using a laser biometer at central fixation conditions.
Measured: Baseline - 24-months
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.
Measured: Baseline - 24-months
Near visual acuity (uniocular and binocular)
Tested using near logMAR ETDRS at 40 cm.
Measured: Baseline - 24-months
Reading speed
Measured with the Wilkins Rate of Reading test.
Measured: Baseline - 24-months
Pupil diameter
Measured using an autorefractor.
Measured: Baseline - 24-months
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.
Measured: Baseline - 24-months
Spectacle correction
Current spectacle prescription.
Measured: Baseline - 24-months
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.
Measured: Baseline - 24-months
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.
Measured: Baseline - 24-months
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).
Measured: Baseline - 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start3 Apr 2019
- Primary completion29 Feb 2024 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, randomised, double-masked, placebo-controlled superiority trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Augusto Azuara-Blanco, PhD FRCOphth, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690089
- Sponsor's protocol ID
- 17097AB-AS
- Other IDs
- 2017-004108-23, 2017
- Acronym
- CHAMP-UK
- Status last verified
- Sep 2023
- First submitted
- 20 Aug 2018
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Azuara-Blanco A, Logan NS, McConnell E, Kearney S, Kirk G, Jones S, McDowell C, Murphy L, O'Hanlon G, McFarland M, Painter S, Muthusamy B, Nabili S, Preston J, Flitcroft I, Loughman J, Mackey D, Lee S, Dahlmann-Noor A, Congdon N, Hogg RE, Hammond CJ, Saunders K, Allen PM, Strang N, Clarke M. Low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the UK (CHAMP-UK). BMJ. 2026 Jun 11;393:e086698. doi: 10.1136/bmj-2025-086698.
PubMed 42276557Azuara-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.
PubMed 31653669
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03690089
- Acronym / sponsor ID
- CHAMP-UK / 17097AB-AS
- Conditions
- Myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, randomised, double-masked, placebo-controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Atropine 0.01%) | Experimental | Drug: Atropine SulfateThe intervention group will receive 0.01% atropine sulfate eye drops, administered once daily for two years. |
| Placebo Group | Placebo comparator | Other: PlaceboThe control group will receive placebo eye drops, administered once daily for two years. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine SulfateAtropine 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. | Drug | Intervention Group (Atropine 0.01%) |
| PlaceboPlacebo eye drops which consist of 10mls of a clear colourless solution of benzalkonium chloride 0.01% w/v in sterile water. | Other | Placebo Group |
Primary outcome
Spherical equivalent refractive error (i.e. myopia severity)
Time frame: Baseline - 24-months
Spherical equivalent refractive error (i.e., myopia severity) of both eyes measured by autorefractor under cycloplegia (adjusted for baseline).
10 secondary outcomes
Central axial length
Time frame: Baseline - 24-months
Best corrected distance visual acuity (BCdVA) (uniocular and binocular)
Time frame: Baseline - 24-months
Near visual acuity (uniocular and binocular)
Time frame: Baseline - 24-months
Reading speed
Time frame: Baseline - 24-months
Pupil diameter
Time frame: Baseline - 24-months
Accommodation
Time frame: Baseline - 24-months
Spectacle correction
Time frame: Baseline - 24-months
Eye drop tolerability
Time frame: Baseline - 24-months
Adverse event rates and allergic reactions rates
Time frame: Baseline - 24-months
Quality of Life: measured using the EQ-5D-Y
Time frame: Baseline - 24-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 42276557Azuara-Blanco A, Logan NS, McConnell E, Kearney S, Kirk G, Jones S, McDowell C, Murphy L, O'Hanlon G, McFarland M, Painter S, Muthusamy B, Nabili S, Preston J, Flitcroft I, Loughman J, Mackey D, Lee S, Dahlmann-Noor A, Congdon N, Hogg RE, Hammond CJ, Saunders K, Allen PM, Strang N, Clarke M. Low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the UK (CHAMP-UK). BMJ. 2026 Jun 11;393:e086698. doi: 10.1136/bmj-2025-086698.
- Derived from this study: PubMed 31653669Azuara-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Augusto Azuara-Blanco, PhD FRCOphth principal investigator
Queen's University, Belfast
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atropine Sulfate in people with Myopia, run by Belfast Health and Social Care Trust at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical equivalent refractive error (i.e. myopia severity) (time frame: Baseline - 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690089, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.