MyopiaEUCALYPTUSNCT06034327
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
A study testing Single vision, impact-resistant spectacle lenses; Test Arm in people with Myopia and Juvenile Myopia, run by SightGlass Vision, Inc. at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Juvenile Myopia, Myopia Progression
- What is being tested?
- Single vision, impact-resistant spectacle lenses; Test Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 Sep 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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)];
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Athens Eye Care
Athens, Ohio, 45701
Jen Brite, 740-594-2271
Shane Foster, OD
- Recruiting
Texas State Optical - Dowlen
Beaumont, Texas, 77706
Bobbie Hampton, 409-899-9999
Samir Patel, OD
- Recruiting
Bellaire Family Eye Care
Bellaire, Texas, 77401
Ashley Tucker, OD
Ashley Tucker, OD
- Recruiting
New England College of Optometry
Boston, Massachusetts, 02115
Lilly Cheam, 617-266-2030
Katherine Green, OD
- Recruiting
Ilinois College of Optometry
Chicago, Illinois, 60616
Jessica Martinez, 312-949-7000
Yi Pang, OD
- Recruiting
Procare Vision Centers, Inc.
Granville, Ohio, 43023
Katherine Bickle, OD
Katherine Bickle, OD
- Recruiting
Omega Vision Center
Longwood, Florida, 32779
Renee Warren, 407-869-4733
Christopher Pearson, OD
- Recruiting
Marietta Eye Clinic
Marietta, Georgia, 30060
Doreatha Kennerly, 678-803-2600 ext. 2522
Monica Bratton, MD
- Recruiting
Elsa Pao, OD
Oakland, California, 94607
Vanessa Chen, 510-238-9797
Elsa Pao, OD
- Recruiting
Kannarr Eye Care
Pittsburg, Kansas, 66762
Megan Compton, RN, 620-235-1737
Shane Kannarr, OD
- Recruiting
Advanced Eyecare PC
Raytown, Missouri, 64133
Tamara Urias, 816-353-1872
Richard Wilson, OD
- Recruiting
Scripps Poway Eyecare
San Diego, California, 92131
Leslie Shan, OD, 858-530-2800
Keith Wan, OD
- Recruiting
Pacific Rims Optometry
San Francisco, California, 94127
Aileen Guzman, 415-655-3937
Selena Chan, OD
- Recruiting
Paje Optometric
Santa Ana, California, 92704
Daisy Magdaleno, 714-557-9492
Vanessa Grichine, OD
About this study
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.
- Conditions
- Myopia, Juvenile Myopia, Myopia Progression
- Being tested
- Single vision, impact-resistant spectacle lenses; Test Arm, Single vision, impact-resistant spectacle lenses; Control Arm
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single vision, impact-resistant spectacle lenses; Test ArmDevice
Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Single vision, impact-resistant spectacle lenses; Control ArmDevice
Single vision, impact-resistant spectacle lenses
| Study group | Role | What they receive |
|---|---|---|
| Test Arm 1 | Experimental | Single vision, impact-resistant spectacle lenses Receives: Device: Single vision, impact-resistant spectacle lenses; Test Arm |
| Test Arm 2 | Other | Single vision, impact-resistant spectacle lenses Receives: Device: Single vision, impact-resistant spectacle lenses; Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical equivalent refraction
Change in spherical equivalent refraction from baseline
Measured: 12 months
Secondary outcomes (1)
Axial length
Change in axial length from baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start18 Sep 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by SightGlass Vision, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SightGlass Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034327
- Sponsor's protocol ID
- CPRO-2304-001
- Acronym
- EUCALYPTUS
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
- ClinicalTrials.gov ID
- NCT06034327
- Acronym / sponsor ID
- EUCALYPTUS / CPRO-2304-001
- Conditions
- Myopia, Juvenile Myopia, Myopia Progression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SightGlass Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm 1 | Experimental | Device: Single vision, impact-resistant spectacle lenses; Test ArmSingle vision, impact-resistant spectacle lenses |
| Test Arm 2 | Other | Device: Single vision, impact-resistant spectacle lenses; Control ArmSingle vision, impact-resistant spectacle lenses |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single vision, impact-resistant spectacle lenses; Test ArmUse of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia | Device | Test Arm 1 |
| Single vision, impact-resistant spectacle lenses; Control ArmSingle vision, impact-resistant spectacle lenses | Device | Test Arm 2 |
Primary outcome
Spherical equivalent refraction
Time frame: 12 months
Change in spherical equivalent refraction from baseline
1 secondary outcome
Axial length
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single vision, impact-resistant spectacle lenses; Test Arm in people with Myopia and Juvenile Myopia, run by SightGlass Vision, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer S Hill, BS (678-361-4877, jhill@sightglassvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical equivalent refraction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.