Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens (EUCALYPTUS)

December 24, 2025 updated by: SightGlass Vision, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94607
        • Recruiting
        • Elsa Pao, OD
        • Contact:
          • Vanessa Chen
          • Phone Number: 510-238-9797
        • Principal Investigator:
          • Elsa Pao, OD
      • San Diego, California, United States, 92131
        • Recruiting
        • Scripps Poway Eyecare
        • Principal Investigator:
          • Keith Wan, OD
        • Contact:
          • Leslie Shan, OD
          • Phone Number: 858-530-2800
      • San Francisco, California, United States, 94127
        • Recruiting
        • Pacific Rims Optometry
        • Contact:
          • Aileen Guzman
          • Phone Number: 415-655-3937
        • Principal Investigator:
          • Selena Chan, OD
      • Santa Ana, California, United States, 92704
        • Recruiting
        • Paje Optometric
        • Contact:
          • Daisy Magdaleno
          • Phone Number: 714-557-9492
        • Principal Investigator:
          • Vanessa Grichine, OD
    • Florida
      • Longwood, Florida, United States, 32779
        • Recruiting
        • Omega Vision Center
        • Contact:
          • Renee Warren
          • Phone Number: 407-869-4733
        • Principal Investigator:
          • Christopher Pearson, OD
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Marietta Eye Clinic
        • Contact:
          • Doreatha Kennerly
          • Phone Number: 2522 678-803-2600
        • Principal Investigator:
          • Monica Bratton, MD
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Recruiting
        • Ilinois College of Optometry
        • Contact:
          • Jessica Martinez
          • Phone Number: 312-949-7000
        • Principal Investigator:
          • Yi Pang, OD
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Recruiting
        • Kannarr Eye Care
        • Contact:
          • Megan Compton, RN
          • Phone Number: 620-235-1737
        • Principal Investigator:
          • Shane Kannarr, OD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • New England College of Optometry
        • Principal Investigator:
          • Katherine Green, OD
        • Contact:
          • Lilly Cheam
          • Phone Number: 617-266-2030
    • Missouri
      • Raytown, Missouri, United States, 64133
        • Recruiting
        • Advanced Eyecare PC
        • Principal Investigator:
          • Richard Wilson, OD
        • Contact:
          • Tamara Urias
          • Phone Number: 816-353-1872
    • Ohio
      • Athens, Ohio, United States, 45701
        • Recruiting
        • Athens Eye Care
        • Contact:
          • Shane Foster, OD
        • Principal Investigator:
          • Shane Foster, OD
        • Contact:
          • Jen Brite
          • Phone Number: 740-594-2271
      • Granville, Ohio, United States, 43023
        • Recruiting
        • ProCare Vision Centers, Inc.
        • Contact:
          • Katherine Bickle, OD
        • Principal Investigator:
          • Katherine Bickle, OD
    • Texas
      • Beaumont, Texas, United States, 77706
        • Recruiting
        • Texas State Optical - Dowlen
        • Contact:
          • Bobbie Hampton
          • Phone Number: 409-899-9999
        • Principal Investigator:
          • Samir Patel, OD
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Bellaire Family Eye Care
        • Contact:
          • Ashley Tucker, OD
        • Principal Investigator:
          • Ashley Tucker, OD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Test Arm 2
Single vision, impact-resistant spectacle lenses
Device: Single vision, impact-resistant spectacle lenses; Control Arm
Single vision, impact-resistant spectacle lenses
Experimental: Test Arm 1
Single vision, impact-resistant spectacle lenses
Device: Single vision, impact-resistant spectacle lenses; Test Arm
Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spherical equivalent refraction
Time Frame: 12 months
Change in spherical equivalent refraction from baseline
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length
Time Frame: 12 months
Change in axial length from baseline
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SightGlass Vision, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPRO-2304-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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