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

NCT ID: NCT03690089

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-03
• Study Completion Date: 2027-02-02

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group (Atropine 0.01%)

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

Group Type: EXPERIMENTAL

Atropine Sulfate

Intervention Type: 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.

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Belfast Health and Social Care Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Augusto Azuara-Blanco, PhD FRCOphth

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

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

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31653669 (View on PubMed)

Other Identifiers

2017-004108-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17097AB-AS

Identifier Type: -

Identifier Source: org_study_id