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

Phase 2

Not yet recruiting

• Conditions: Myopia
• Interventions: Drug: Atropine 0.025%; Device: Single vision Contact lens; Device: Multizonal contact lens; Drug: Placebo

• Registration Number: NCT06765603
• Lead Sponsor: Singapore National Eye Centre

Brief Summary

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.

Detailed Description

see above

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Study Start: 2025-02-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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.
• Have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria

• 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.
• Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.
• Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit-lamp findings (eg. edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.
• Any central corneal scar or corneal distortion resulting from ocular diseases or previous hard or rigid permeable contact lens wear.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atropine - SVCL	Atropine 0.025%	Atropine 0.025%
Atropine - SVCL	Single vision Contact lens	Atropine 0.025%
Atropine- multizonal CL	Atropine 0.025%	Atropine 0.025% and multizonal CL
Atropine- multizonal CL	Multizonal contact lens	Atropine 0.025% and multizonal CL
Multizonal CL - placebo drop	Multizonal contact lens	Multizonal CL
Multizonal CL - placebo drop	Placebo	Multizonal CL
Placebo drop and SVCL	Placebo	Placebo
Placebo drop and SVCL	Single vision Contact lens	Placebo

Primary Outcome Measures

Name	Time	Method
Change in spherical equivalent	12 months	Change in spherical equivalent at 12 months

Secondary Outcome Measures

Name	Time	Method
Change in axial length	12 months	Change in axial length at 12 months