NCT05174780

Brief Summary

The purpose of this study is to demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

December 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

December 13, 2021

Last Update Submit

December 19, 2025

Conditions

Myopia

Keywords

spectaclemyopia controlmyopiaHALStellestEssilor

Outcome Measures

Primary Outcomes (2)

  • Axial length

    Change in axial length from baseline

    36 Months

  • Cycloplegic spherical equivalent refraction

    Change in cycloplegic spherical equivalent refraction from baseline

    36 Months

Secondary Outcomes (2)

  • Axial length

    24 Months

  • Cycloplegic spherical equivalent refraction

    24 Months

Study Arms (2)

Innovative myopia control spectacle lens

EXPERIMENTAL
Device: innovative myopia control spectacle lens

Single vision spectacle lens

PLACEBO COMPARATOR
Device: Single vision spectacle lens

Interventions

innovative myopia control spectacle lensDEVICE

using a innovative spectacle lens to control myopia progression

Innovative myopia control spectacle lens
Single vision spectacle lensDEVICE

single vision spectacle lens for myopia and astigmatism correction

Single vision spectacle lens

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Equal to or greater than 6 years and not older than 12 years at time of informed consent and assent.
  • Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.50 D in each eye.
  • Astigmatism, if present, of not more than 1.50 D.
  • Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
  • Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
  • Agree to wear spectacles for ≥10 hours/day at least 6 days/week.
  • Willingness and ability to participate in trial for 3 years and attend scheduled visits.

You may not qualify if:

  • History of myopia control intervention (e.g., atropine, orthokeratology, multifocal contact lenses, etc.)
  • Strabismus by cover test at near or distance wearing correction.
  • Amblyopia
  • Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.).
  • Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
  • Current or anticipated use of growth hormones.
  • Participation in any clinical study within 30 days of the Baseline visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Scripps Poway Optometry

San Diego, California, 92131, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

New England College of Optometry

Boston, Massachusetts, 02115, United States

Location

SUNY College of Optometry

New York, New York, 10036, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Mann Eye Institute

Houston, Texas, 77002, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 3, 2022

Study Start

December 29, 2021

Primary Completion

October 20, 2025

Study Completion

October 20, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

US(9)