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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control

NCT05478356

Myopia

UNKNOWN NA

Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control

NCT06358755

Myopia

ACTIVE_NOT_RECRUITING NA

Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate

NCT03374306

Myopia

COMPLETED NA

Influence of Corneal Biomechanical Properties on Myopia Control

NCT05090592

Myopia

UNKNOWN

Myopia Intervention in Children and Adolescents and Establishment of a Precise Intervention Model

NCT05357326

Myopia

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

see above

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

RCT

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atropine - SVCL

Atropine 0.025%

Group Type EXPERIMENTAL

Atropine 0.025%

Intervention Type DRUG

Atropine 0.025%

Single vision Contact lens

Intervention Type DEVICE

Single vision contact lens

Atropine- multizonal CL

Atropine 0.025% and multizonal CL

Group Type ACTIVE_COMPARATOR

Atropine 0.025%

Intervention Type DRUG

Atropine 0.025%

Multizonal contact lens

Intervention Type DEVICE

Multizonal CL

Multizonal CL - placebo drop

Multizonal CL

Group Type ACTIVE_COMPARATOR

Multizonal contact lens

Intervention Type DEVICE

Multizonal CL

Placebo

Intervention Type DRUG

Placebo

Placebo drop and SVCL

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Single vision Contact lens

Intervention Type DEVICE

Single vision contact lens

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atropine 0.025%

Intervention Type DRUG

Multizonal contact lens

Multizonal CL

Intervention Type DEVICE

Placebo

Intervention Type DRUG

Single vision Contact lens

Single vision contact lens

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No