Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression

ConditionMyopia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-13
SponsorSingapore National Eye Centre

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

Treatment groups

180 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators