Evaluating the Efficacy of the Combination of Multi-zonal... | NCT06765603

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

NCT06765603

Sponsor

Singapore National Eye Centre

Status

Not yet recruiting

Last Update Posted

Jan 9, 2025Actual

Enrollment

180Estimated

Phase

Phase 2

Conditions

Myopia

Interventions

Atropine 0.025%
Multizonal contact lens
Placebo
Single vision Contact lens

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jan 3, 2025

First Submission Date that Met QC Criteria

Jan 3, 2025

First Posted Date

Jan 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2025

Last Update Posted Date

Jan 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atropine - SVCL	Experimental	Atropine 0.025%	Drug: Atropine 0.025% Device: Single vision Contact lens
Atropine- multizonal CL	Active Comparator	Atropine 0.025% and multizonal CL	Drug: Atropine 0.025% Device: Multizonal contact lens
Multizonal CL - placebo drop	Active Comparator	Multizonal CL	Device: Multizonal contact lens Drug: Placebo
Placebo drop and SVCL	Placebo Comparator	Placebo	Drug: Placebo Device: Single vision Contact lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atropine 0.025%	Drug	Atropine 0.025%	Atropine - SVCL Atropine- multizonal CL

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

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases