CClinicalTrials.gg
RecruitingNCT06034327EUCALYPTUSUpdated Dec 29, 2025

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

An interventional study of Single vision, impact-resistant spectacle lenses; Test Arm and Single vision, impact-resistant spectacle lenses; Control Arm in Myopia, Juvenile Myopia and Myopia Progression, sponsored by SightGlass Vision, Inc.. Recruiting at 14 sites in United States. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.

Sponsored by SightGlass Vision, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia
  • Juvenile Myopia
  • Myopia Progression

Browse trials for

03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

SightGlass Vision, Inc. is the lead sponsor of 14 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Test Arm 1

    Single vision, impact-resistant spectacle lenses

    Device: Single vision, impact-resistant spectacle lenses; Test Arm

  • Other
    Test Arm 2

    Single vision, impact-resistant spectacle lenses

    Device: Single vision, impact-resistant spectacle lenses; Control Arm

Interventions

  • DeviceSingle vision, impact-resistant spectacle lenses; Test Arm

    Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia

  • DeviceSingle vision, impact-resistant spectacle lenses; Control Arm

    Single vision, impact-resistant spectacle lenses

06

What researchers measure

Primary outcomes

  1. Spherical equivalent refraction

    Change in spherical equivalent refraction from baseline

    Time frame: 12 months

Secondary outcomes

  1. Axial length

    Change in axial length from baseline

    Time frame: 12 months

07

Study locations

14 of 14 sites recruiting
  • Elsa Pao, OD
    Oakland, California 94607, United States
    • Vanessa Chen · Contact · 510-238-9797
    • Elsa Pao, OD · Principal investigator
    Recruiting
  • Scripps Poway Eyecare
    San Diego, California 92131, United States
    • Leslie Shan, OD · Contact · 858-530-2800
    • Keith Wan, OD · Principal investigator
    Recruiting
  • Pacific Rims Optometry
    San Francisco, California 94127, United States
    • Aileen Guzman · Contact · 415-655-3937
    • Selena Chan, OD · Principal investigator
    Recruiting
  • Paje Optometric
    Santa Ana, California 92704, United States
    • Daisy Magdaleno · Contact · 714-557-9492
    • Vanessa Grichine, OD · Principal investigator
    Recruiting
  • Omega Vision Center
    Longwood, Florida 32779, United States
    • Renee Warren · Contact · 407-869-4733
    • Christopher Pearson, OD · Principal investigator
    Recruiting
  • Marietta Eye Clinic
    Marietta, Georgia 30060, United States
    • Doreatha Kennerly · Contact · 678-803-2600
    • Monica Bratton, MD · Principal investigator
    Recruiting
  • Ilinois College of Optometry
    Chicago, Illinois 60616, United States
    • Jessica Martinez · Contact · 312-949-7000
    • Yi Pang, OD · Principal investigator
    Recruiting
  • Kannarr Eye Care
    Pittsburg, Kansas 66762, United States
    • Megan Compton, RN · Contact · 620-235-1737
    • Shane Kannarr, OD · Principal investigator
    Recruiting
  • New England College of Optometry
    Boston, Massachusetts 02115, United States
    • Lilly Cheam · Contact · 617-266-2030
    • Katherine Green, OD · Principal investigator
    Recruiting
  • Advanced Eyecare PC
    Raytown, Missouri 64133, United States
    • Tamara Urias · Contact · 816-353-1872
    • Richard Wilson, OD · Principal investigator
    Recruiting
  • Athens Eye Care
    Athens, Ohio 45701, United States
    • Jen Brite · Contact · 740-594-2271
    • Shane Foster, OD · Contact
    • Shane Foster, OD · Principal investigator
    Recruiting
  • Procare Vision Centers, Inc.
    Granville, Ohio 43023, United States
    • Katherine Bickle, OD · Contact
    • Katherine Bickle, OD · Principal investigator
    Recruiting
  • Texas State Optical - Dowlen
    Beaumont, Texas 77706, United States
    • Bobbie Hampton · Contact · 409-899-9999
    • Samir Patel, OD · Principal investigator
    Recruiting
  • Bellaire Family Eye Care
    Bellaire, Texas 77401, United States
    • Ashley Tucker, OD · Contact
    • Ashley Tucker, OD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06034327
Lead sponsor
SightGlass Vision, Inc.
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Sep 18, 2023
Primary completion
Jan 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Dec 29, 2025

Study contacts

Jennifer S Hill, BS
Contact
jhill@sightglassvision.com
678-361-4877
Vanessa Tasso, MA, MBA
Contact
vtasso@sightglassvision.com
949-751-7039

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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