NCT07229352

Brief Summary

The aim of this study is evaluate and compare the mobility performance of children in daily activities while wearing single vision spectacle lenses (control) versus myopia control spectacle lenses (test).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
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 Progress18%
Feb 2026Jul 2027

First Submitted

Initial submission to the registry

November 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

November 12, 2025

Last Update Submit

April 29, 2026

Conditions

MyopiaMyopia ProgressionJuvenile Myopia

Outcome Measures

Primary Outcomes (3)

  • Reaction time: the time elapsed between the appearance or activation of a visual stimulus and the initiation of the participant's physical response

    2 months

  • Movement time: the time taken to complete the motor response after it has been initiated.

    2 months

  • Response accuracy: the correctness of the participant's response to each visual stimulus, measured by the number or percentage of correctly identified or responded-to stimuli.

    2 months

Secondary Outcomes (1)

  • Gait cycle events, such as initial foot contact with the ground and toe-off. It will be used to assess whether the type of eyewear affects natural gait patterns or mobility during peripheral vision tasks.

    2 months

Study Arms (2)

SightGlass Vision Test Arm 1

EXPERIMENTAL

Single vision, impact-resistant spectacle lenses

Device: Novel spectacle lens design

SightGlass Vision Test Arm 2

EXPERIMENTAL

Single vision, impact-resistant spectacle lenses

Device: Spectacle lenses

Interventions

Novel spectacle lens designDEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

SightGlass Vision Test Arm 1
Spectacle lensesDEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

SightGlass Vision Test Arm 2

Eligibility Criteria

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

You may qualify if:

  • Are between the ages of 6 and 12 years of age (inclusive) at the time of informed consent/assent.
  • Can achieve a corrected visual acuity of 20/20 best-corrected (or equivalent logMAR).
  • Have undergone a self-reported oculo-visual examination within the past two years.
  • Have no active ocular disease.
  • Are willing and able to adhere to instructions, study procedures, and maintain the appointment schedule.
  • Have not previously worn or participated in myopia control contact lenses for more than one month and are not currently undergoing any form of myopia control treatment.
  • The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.

You may not qualify if:

  • A participant will be excluded from the study if they meet any of the following conditions:
  • Have any systemic disease that affects ocular health.
  • Are currently using or have used, within the past 7 days, any systemic or topical medications that may impact ocular health.
  • Are currently using or have used any topical ophthalmic agents with anti-muscarinic properties within 7 days prior to enrollment or at any point during the study. This includes, but is not limited to, atropine, scopolamine, pirenzepine, tropicamide, cyclopentolate, and homatropine.
  • Have used any oral agents with anti-muscarinic properties for a chronic period (2 months or more) or short-term (within 7 days prior to enrollment). This includes, but is not limited to, gastrointestinal anti-spasmodic medications containing atropine, hyoscyamine, and dicyclomine.
  • Have known developmental delays.
  • Have participated in another clinical study in the last 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwestern University Arizona College of Optometry

Glendale, Arizona, 85308, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Jennifer Hill

CONTACT

6783614877jhill@sightglassvision.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2025

First Posted

November 17, 2025

Study Start

February 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

US(1)