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 groupsLocations
14California
Elsa Pao, OD94607, Oakland United States
Scripps Poway Eyecare92131, San Diego United States
Pacific Rims Optometry94127, San Francisco United States
Paje Optometric92704, Santa Ana United States
Sponsors and collaborators
SightGlass Vision, Inc.
Lead sponsor
Source ClinicalTrials.gov