Clinical trial NCT06034327: Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
Official title: Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Juvenile Myopia
Myopia Progression
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
5. The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
7. Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
8. Willingness to participate in the trial for 24 months without contact lens wear;
9. 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.

Exclusion Criteria:

1. Subject has previously or currently wears contact lenses (greater than 1-month usage);
2. Current or prior use of bifocals, progressive addition spectacle lenses
3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
4. Amblyopia in either eye;
5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
6. Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\];
7. Known allergy to proparacaine, tetracaine, or tropicamide;
8. Participation in any investigational clinical study within 30 days of the Baseline visit;
9. Subject's sibling or other household member is already enrolled in this trial.

Primary outcomes:
measure: Spherical equivalent refraction
timeFrame: 12 months
Secondary outcomes:
measure: Axial length
timeFrame: 12 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Elsa Pao, OD
state: California
city: San Diego
country: United States
facility: Scripps Poway Eyecare
state: California
city: San Francisco
country: United States
facility: Pacific Rims Optometry
state: California
city: Santa Ana
country: United States
facility: Paje Optometric
state: California
city: Longwood
country: United States
facility: Omega Vision Center
state: Florida
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Chicago
country: United States
facility: Ilinois College of Optometry
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: Raytown
country: United States
facility: Advanced Eyecare PC
state: Missouri
city: Athens
country: United States
facility: Athens Eye Care
state: Ohio
city: Granville
country: United States
facility: Procare Vision Centers, Inc.
state: Ohio
city: Beaumont
country: United States
facility: Texas State Optical - Dowlen
state: Texas
city: Bellaire
country: United States
facility: Bellaire Family Eye Care
state: Texas
Study officials:
References: