Health TrialsbyHealthPanel

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

ConditionsMyopiaJuvenile MyopiaMyopia Progression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorSightGlass Vision, Inc.

About this trial

This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy.

This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children 6 - 8 years of age (inclusive) at time of informed consent/assent;

Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;

Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;

Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;

Disqualifiers

Subject has previously or currently wears contact lenses (greater than 1-month usage);

Current or prior use of bifocals, progressive addition spectacle lenses

Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);

Amblyopia in either eye;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single vision, impact-resistant spectacle lenses; Test Arm

    Device

    Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia

  • Single vision, impact-resistant spectacle lenses; Control Arm

    Device

    Single vision, impact-resistant spectacle lenses

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Test Arm 1Experimental treatment 1 intervention
Group B: Test Arm 2Other 1 intervention

Trial outcomes

Primary outcomes

1

Spherical equivalent refraction

Change in spherical equivalent refraction from baseline

Time frame
12 months

Secondary outcomes

1

Axial length

Change in axial length from baseline

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SightGlass Vision, Inc.

Lead sponsor

Source ClinicalTrials.gov
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