Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
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
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
Treatments tested in this trial
- Single vision, impact-resistant spectacle lenses; Test Arm
- Single vision, impact-resistant spectacle lenses; Control Arm
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov