NCT06765603

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
45mo left

Started Feb 2025

Longer than P75 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Feb 2025Dec 2029

First Submitted

Initial submission to the registry

January 3, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

3.9 years

First QC Date

January 3, 2025

Last Update Submit

January 3, 2025

Conditions

Myopia

Keywords

myopia intervention

Outcome Measures

Primary Outcomes (1)

  • Change in spherical equivalent

    Change in spherical equivalent at 12 months

    12 months

Secondary Outcomes (1)

  • Change in axial length

    12 months

Study Arms (4)

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 lensDrug: Placebo

Placebo drop and SVCL

PLACEBO COMPARATOR

Placebo

Drug: PlaceboDevice: Single vision Contact lens

Interventions

Atropine 0.025%DRUG

Atropine 0.025%

Atropine - SVCLAtropine- multizonal CL
Multizonal contact lensDEVICE

Multizonal CL

Atropine- multizonal CLMultizonal CL - placebo drop
PlaceboDRUG

Placebo

Multizonal CL - placebo dropPlacebo drop and SVCL
Single vision Contact lensDEVICE

Single vision contact lens

Atropine - SVCLPlacebo drop and SVCL

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

audrey chia, PhD

CONTACT

65 62277255audrey.chia.w.l@singhealth.com.sg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: RCT
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pi

Study Record Dates

First Submitted

January 3, 2025

First Posted

January 9, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

January 9, 2025

Record last verified: 2025-01