Recruiting

DG1 Spectacle Lens

Sponsor:

HOYA Lens Thailand LTD.

Code:

NCT06781931

Conditions

Myopia

Eligibility Criteria

Sex: All

Age: 7 - 10

Healthy Volunteers: Not accepted

Interventions

DG1 Spectacle Lens

Single Vision Spectacle Lens

Study Details

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

Study ID

NCT06781931

Start date

Jan 21, 2025

Status verified date

Apr, 2025

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 10

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject and parent (or guardian) able and willing to provide assent and consent respectively.
2. The subject and parent (or guardian) must attend required study visits and adhere to study requirements.
3. 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.
4. 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.
5. Age of subject at time of parent (or guardian) consent and subject assent: 7 to 10 years old (inclusive).
6. Cycloplegic autorefraction spherical equivalent refraction (SER): -1.00 to -5.00 D in each eye at the screening visit.
7. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye at the screening visit.
8. Cycloplegic spherical equivalent autorefraction (SER) anisometropia of 1.50 D or less at the screening visit.
9. Monocular cycloplegic best corrected distance visual acuity (BCDVA) equal to or better than log MAR 0.10 in each eye at the screening visit.

Exclusion Criteria:

1. Subjects with allergy to fluorescein, benoxinate, proparacaine, cyclopentolate or tropicamide eye drops.
2. Subjects with ocular or systemic abnormalities that might be expected to affect visual functions or refractive development.
3. 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.
4. Subjects with, or a medical history of, strabismus.
5. Subjects with a medical history of binocular vision abnormalities or accommodation abnormalities based on the opinion of the investigator.
6. Subjects with, or history of, amblyopia.
7. Subjects who have participated in a clinical trial within 30 days prior to entry into this study or during participation.
8. Subjects with a history of intraocular surgery.
9. 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.
10. 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).
11. 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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DG1 Spectacle Lens

sham comparator: Single Vision Spectacle Lens

Interventions

DG1 Spectacle Lens

DG1 spectacle lens, daily wear for 36 months

Single Vision Spectacle Lens

Single vision spectacle lens, daily wear for 36 months

Primary outcome measure

  • Co-Primary Effectiveness Endpoints: Spherical equivalent refraction and Axial Length [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

William Zhou, Global Head of Clinical Affairs

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

Locations

Irvine Vision Center

Recruiting

Irvine, California, United States, 92618

Columbia Eye Associates & Family Focus Eye Care

Recruiting

Gainesville, Florida, United States, 32605

Coan Eye Care and Optical Boutique

Recruiting

Ocoee, Florida, United States, 34761

Illinois College of Optometry

Recruiting

Chicago, Illinois, United States, 60616

Complete Eye Care of Medina

Recruiting

Medina, Minnesota, United States, 55340

Oculus Research, Inc.

Recruiting

Garner, North Carolina, United States, 27529

ProCare Vision Centers, Inc.

Recruiting

Granville, Ohio, United States, 43023

EyeCare Professionals of Powell

Recruiting

Powell, Ohio, United States, 43065

Southern College of Optometry

Recruiting

Memphis, Tennessee, United States, 38104

Virginia Pediatric Eye Center

Recruiting

Virginia Beach, Virginia, United States, 23452

More Information

Sponsor

HOYA Lens Thailand LTD.

Last update posted

Jun 24, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by HOYA Lens Thailand LTD. on 2025-06-24.