NCT06034327 · SightGlass Vision, Inc.
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
(EUCALYPTUS)
What this study is about
This is a conventional effectiveness trial to validate the results from previous clinical trials for younger children; the 12-month effectiveness results will be used to predict the 3-year treatment effectiveness. This is a randomly assigned, controlled (1:1), multisite, subject- and observer-masked, 2-treatment group$1 parallel group study.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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;
- 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;
- 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);
- 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;
- Willingness to participate in the trial for 24 months without contact lens wear;
- 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
- 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;
- Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
- Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\];
- Known allergy to proparacaine, tetracaine, or tropicamide;
- Participation in any investigational clinical study within 30 days of the Baseline visit;
- Subject's sibling or other household member is already enrolled in this trial.
Where
- Oakland, California
- San Diego, California
- San Francisco, California
- Santa Ana, California
- Longwood, Florida
- Marietta, Georgia
- Chicago, Illinois
- Pittsburg, Kansas
- Boston, Massachusetts
- Raytown, Missouri
- Athens, Ohio
- Granville, Ohio
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 29, 2025 · Source of record for eligibility and locations