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 range6 Years – 12 Years

SexALL

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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;

What they're measuring

Cycloplegic Autorefraction(SER)

Timeframe: 24 months

Trial details

NCT IDNCT06209320

SponsorZhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-21

View on ClinicalTrials.gov More Myopia trials