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

Primary Purpose

Myopia, Juvenile Myopia, Myopia Progression

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single vision, impact-resistant spectacle lenses; Test Arm
Single vision, impact-resistant spectacle lenses; Control Arm
Sponsored by
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Advanced Eyecare PC
  • Athens Eye Care
  • Procare Vision Centers, Inc.
  • Bellaire Family Eye Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Test Arm 1

Test Arm 2

Arm Description

Single vision, impact-resistant spectacle lenses

Single vision, impact-resistant spectacle lenses

Outcomes

Primary Outcome Measures

Spherical equivalent refraction
Change in spherical equivalent refraction from baseline

Secondary Outcome Measures

Axial length
Change in axial length from baseline

Full Information

First Posted
September 5, 2023
Last Updated
September 5, 2023
Sponsor
SightGlass Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06034327
Brief Title
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
Acronym
EUCALYPTUS
Official Title
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Juvenile Myopia, Myopia Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables will be masked.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Arm 1
Arm Type
Experimental
Arm Description
Single vision, impact-resistant spectacle lenses
Arm Title
Test Arm 2
Arm Type
Other
Arm Description
Single vision, impact-resistant spectacle lenses
Intervention Type
Device
Intervention Name(s)
Single vision, impact-resistant spectacle lenses; Test Arm
Intervention Description
Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Intervention Type
Device
Intervention Name(s)
Single vision, impact-resistant spectacle lenses; Control Arm
Intervention Description
Single vision, impact-resistant spectacle lenses
Primary Outcome Measure Information:
Title
Spherical equivalent refraction
Description
Change in spherical equivalent refraction from baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Axial length
Description
Change in axial length from baseline
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer S Hill, BS
Phone
678-361-4877
Email
jhill@sightglassvision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Tasso, MA, MBA
Phone
949-751-7039
Email
vtasso@sightglassvision.com
Facility Information:
Facility Name
Advanced Eyecare PC
City
Raytown
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Urias
Phone
816-353-1872
Email
turias@eyecarespecialtiesmo.com
First Name & Middle Initial & Last Name & Degree
Richard Wilson, OD
Facility Name
Athens Eye Care
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jen Brite
Email
jen@athenseyecare.com
First Name & Middle Initial & Last Name & Degree
Shane Foster, OD
First Name & Middle Initial & Last Name & Degree
Shane Foster, OD
Facility Name
Procare Vision Centers, Inc.
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Bickle, OD
First Name & Middle Initial & Last Name & Degree
Katherine Bickle, OD
Facility Name
Bellaire Family Eye Care
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Tucker, OD
First Name & Middle Initial & Last Name & Degree
Ashley Tucker, OD

12. IPD Sharing Statement

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

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