DG1 Spectacle Lens for Myopia Progression Control in Children

NCT06781931 | Recruiting FDA Device

• 1 other identifier: DG1-101-KIND
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 10

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children.

• To assess if the DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.75D in cycloplegic spherical equivalent autorefraction refractive error compared to single-vision (SV) spectacles over the study period.
• To assess if DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.3mm in axial elongation compared to SV over the study period. The clinical trial will compare DG1 spectacle lens to single vision spectacle lens. Participants will wear spectacle lenses and return for visits at regularly scheduled intervals through a 36-month follow up visit. All subjects who complete the 36-month visit will continue in the study for an additional 12 months for the rebound evaluation.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Co-Primary Effectiveness Endpoints: Spherical equivalent refraction and Axial Length

  * The mean difference of cycloplegic autorefractive error progression of the test device as compared to control SV spectacles. * The mean difference in axial elongation of the test device as compared to control SV spectacles.

  36 months

Secondary Outcomes (1)

• Corrected Visual Acuity

  24 months

Study Arms (2)

DG1 Spectacle Lens

EXPERIMENTAL

Device: DG1 Spectacle Lens

Single Vision Spectacle Lens

SHAM COMPARATOR

Device: Single Vision Spectacle Lens

Interventions

DG1 Spectacle Lens DEVICE

DG1 spectacle lens, daily wear for 36 months

DG1 Spectacle Lens

Single Vision Spectacle Lens DEVICE

Single vision spectacle lens, daily wear for 36 months

Single Vision Spectacle Lens

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject and parent (or guardian) able and willing to provide assent and consent respectively.
• The subject and parent (or guardian) must attend required study visits and adhere to study requirements.
• Parent (or guardian) understands and accepts random allocation of grouping, and that subject and parent (or guardian) will not be told the group which the subject is randomized to.
• The subject is able and willing to wear provided frames and lenses (spectacles), for an average of 10 hours per day for the entirety of the study.
• Age of subject at time of parent (or guardian) consent and subject assent: 7 to 10 years old (inclusive).
• Cycloplegic autorefraction spherical equivalent refraction (SER): -1.00 to -5.00 D in each eye at the screening visit.
• Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye at the screening visit.
• Cycloplegic spherical equivalent autorefraction (SER) anisometropia of 1.50 D or less at the screening visit.
• Monocular cycloplegic best corrected distance visual acuity (BCDVA) equal to or better than log MAR 0.10 in each eye at the screening visit.

You may not qualify if:

• Subjects with allergy to fluorescein, benoxinate, proparacaine, cyclopentolate or tropicamide eye drops.
• Subjects with ocular or systemic abnormalities that might be expected to affect visual functions or refractive development.
• Subjects who have received treatment of myopia control pharmaceutical medication (e.g., atropine), myopia control contact lenses, other myopia control spectacles, orthokeratology lenses, progressive addition lenses, bifocal lenses, or single vision contact lens prior to entry into the study or during the duration of the study.
• Subjects with, or a medical history of, strabismus.
• Subjects with a medical history of binocular vision abnormalities or accommodation abnormalities based on the opinion of the investigator.
• Subjects with, or history of, amblyopia.
• Subjects who have participated in a clinical trial within 30 days prior to entry into this study or during participation.
• Subjects with a history of intraocular surgery.
• Subjects who, in the judgment of the investigator, have any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment.
• Subjects with pathological myopia (myopia that leads to structural changes in the posterior segment of the eye including posterior staphyloma, myopic maculopathy, and high myopia-associated optic neuropathy).
• Individuals from the same household (i.e., siblings), employees (or family members of employees) of the Principal Investigator/site, employees (or family members of employees) of the Sponsor, and non-readers.

Sponsors & Collaborators

• HOYA Lens Thailand LTD.: lead

Study Sites (10)

Irvine Vision Center

Irvine, California, 92618, United States

RECRUITING

Columbia Eye Associates & Family Focus Eye Care

Gainesville, Florida, 32605, United States

RECRUITING

Coan Eye Care and Optical Boutique

Ocoee, Florida, 34761, United States

RECRUITING

Illinois College of Optometry

Chicago, Illinois, 60616, United States

RECRUITING

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

RECRUITING

Oculus Research, Inc.

Garner, North Carolina, 27529, United States

RECRUITING

ProCare Vision Centers, Inc.

Granville, Ohio, 43023, United States

RECRUITING

EyeCare Professionals of Powell

Powell, Ohio, 43065, United States

RECRUITING

Southern College of Optometry

Memphis, Tennessee, 38104, United States

RECRUITING

Virginia Pediatric Eye Center

Virginia Beach, Virginia, 23452, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

William Zhou, Global Head of Clinical Affairs

CONTACT

833-341-5463; william.zhou@hoya.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 17, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)