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Not yet recruitingNCT06765603Updated Jan 9, 2025

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

A Phase 2 interventional study of Atropine 0.025% and Multizonal contact lens in Myopia, sponsored by Singapore National Eye Centre. Not yet recruiting. Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2025-01-09.

Sponsored by Singapore National Eye Centre · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
7 Years to 13 Years
Sex
All
01

Study 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.

Read the detailed description

see above

02

Conditions studied

  • Myopia

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Keywords

  • myopia intervention
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 180 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Singapore National Eye Centre is the lead sponsor of 84 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Atropine - SVCL

    Atropine 0.025%

    Drug: Atropine 0.025% · Device: Single vision Contact lens

  • Active comparator
    Atropine- multizonal CL

    Atropine 0.025% and multizonal CL

    Drug: Atropine 0.025% · Device: Multizonal contact lens

  • Active comparator
    Multizonal CL - placebo drop

    Multizonal CL

    Device: Multizonal contact lens · Drug: Placebo

  • Placebo comparator
    Placebo drop and SVCL

    Placebo

    Drug: Placebo · Device: Single vision Contact lens

Interventions

  • DrugAtropine 0.025%

    Atropine 0.025%

  • DeviceMultizonal contact lens

    Multizonal CL

  • DrugPlacebo

    Placebo

  • DeviceSingle vision Contact lens

    Single vision contact lens

06

What researchers measure

Primary outcomes

  1. Change in spherical equivalent

    Change in spherical equivalent at 12 months

    Time frame: 12 months

Secondary outcomes

  1. Change in axial length

    Change in axial length at 12 months

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06765603
Lead sponsor
Singapore National Eye Centre
Responsible party
Audrey Wei-Lin Chia (pi, Singapore National Eye Centre) — Principal investigator
First posted
Jan 9, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jan 9, 2025

Study contacts

audrey chia, PhD
Contact
audrey.chia.w.l@singhealth.com.sg
65 62277255

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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