NCT06034327 Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
| NCT ID | NCT06034327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SightGlass Vision, Inc. |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-09-18 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06034327 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 8 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06034327 currently recruiting?
Yes, NCT06034327 is actively recruiting participants. Contact the research team at jhill@sightglassvision.com for enrollment information.
Where is the NCT06034327 trial being conducted?
This trial is being conducted at Oakland, United States, San Diego, United States, San Francisco, United States, Santa Ana, United States and 10 additional locations.
Who is sponsoring the NCT06034327 clinical trial?
NCT06034327 is sponsored by SightGlass Vision, Inc.. The trial plans to enroll 150 participants.