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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: Placebo; Drug: Atropine 0.025%; Device: Single vision Contact lens; Device: Multizonal contact lens

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: audrey chia, PhD; Phone Number: 65 62277255; Email: audrey.chia.w.l@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atropine - SVCL; Atropine 0.025%	Drug: Atropine 0.025%; Atropine 0.025%; Device: Single vision Contact lens; Single vision contact lens
Active Comparator: Atropine- multizonal CL; Atropine 0.025% and multizonal CL	Drug: Atropine 0.025%; Atropine 0.025%; Device: Multizonal contact lens; Multizonal CL
Active Comparator: Multizonal CL - placebo drop; Multizonal CL	Drug: Placebo; Placebo; Device: Multizonal contact lens; Multizonal CL
Placebo Comparator: Placebo drop and SVCL; Placebo	Drug: Placebo; Placebo; Device: Single vision Contact lens; Single vision contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spherical equivalent	Change in spherical equivalent at 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in axial length	Change in axial length at 12 months	12 months

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: myopia intervention
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adjuvants, Anesthesia; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Mydriatics; Atropine
• Other Study ID Numbers: R1867/109/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No