A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops (NCT06209320) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops
China777 participantsStarted 2022-03-15
Plain-language summary
A randomized, double-blind, placebo-controlled, multicenter, phase III clinical study of the efficacy and safety of two low-concentration atropine sulfate eye drops in slowing the progression of myopia in children
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Child (female or male) aged 6 to 12 years.
. Myopia (SER of at least -0.50 D and no more myopic than -6.00 D) in each eye as measuredby cycloplegic autorefraction.
. If present, astigmatism of ≤1.50 D in each eye as measured by cycloplegic autorefraction.
. Anisometropia SER of \< 1.50 D as measured by cycloplegic autorefraction.
Exclusion criteria
. Have used other myopia control methods other than those used in this study, such as instruments (orthokeratology lenses, multifocal glasses, progressive glasses), drugs (atropine, etc.); Only single vision glasses are allowed for myopia correction;
. Have used myopic control methods such as traditional Chinese medicine, auricular acupuncture, massage, and reverse beat within 30 days before screening;
. Use of any local or systemic antimuscarinic/anticholinergic medication (e.g., atropine, scopolamine, tropicamide, phenamine, diphenhydramine, oxytropine, tricyclic antidepressant, etc.) within 21 days before screening; Allowing for tests such as cycloplegic optometry;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.