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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Atropine 0.025%
Drug
Atropine 0.025%
Multizonal contact lens
Device
Multizonal CL
Placebo
Drug
Placebo
Single vision Contact lens
Device
Single vision contact lens

Treatment groups

180 Participants

are divided into 4 treatment groups

Group A: Atropine - SVCLExperimental treatment 2 interventions

Group B: Atropine- multizonal CLActive comparator 2 interventions

Group C: Multizonal CL - placebo dropActive comparator 2 interventions

Group D: Placebo drop and SVCLPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Change in spherical equivalent

Change in spherical equivalent at 12 months

Time frame

12 months

Secondary outcomes

Change in axial length

Change in axial length at 12 months

Time frame

12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Singapore National Eye Centre

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: