About this trial
The aim of the study is to explore efficacy of combination Atropine and multifocal CL. Randomized Control Trial including 4 arms: Atropine / multizonal CL; Atropine/ SV CL, Placebo drop/ multizonal CL; Placebo drop/ SV CL. Followed over 1 year with outcome measure of change in spherical equivalent and axial length.
Eligibility criteria
Qualifiers
Between 7 and 12 (inclusive) years of age at the time of screening.
spherical equivalent of cycloplegic objective refraction (by autorefraction) range of -0.75 D to -4.50 D (inclusive) in each eye.
Refractive cylinder less than 1.12 D (inclusive)
Best-corrected visual acuity (BCVA) of 0.04 logMAR or better in each eye, with difference less than 0.20 logMAR between eyes.
Disqualifiers
Past or current use of myopia control treatment or involvement in previous myopia control study
Any current or seasonal use of ocular medication (eg. for allergy or chronic blepharitis).
hypersensitivity or allergic reaction to atropine, cyclopentolate, topical anesthetics or study approved rewetting drop solutions available in local markets.
previous history or signs of a contact lens-related corneal inflammatory event (e.g., past ulcer or scar) that may contraindicate contact lens wear.
Trial design
Treatments tested in this trial
- Atropine 0.025%
- Multizonal contact lens
- Placebo
- Single vision Contact lens