DG1 Spectacle Lens for Myopia Progression Control in Children

Last updated: June 18, 2025
Sponsor: HOYA Lens Thailand LTD.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

DG1 Spectacle Lens

Single Vision Spectacle Lens

Clinical Study ID

NCT06781931
DG1-101-KIND
  • Ages 7-10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject and parent (or guardian) able and willing to provide assent and consentrespectively.

  2. The subject and parent (or guardian) must attend required study visits and adhere tostudy requirements.

  3. Parent (or guardian) understands and accepts random allocation of grouping, and thatsubject and parent (or guardian) will not be told the group which the subject israndomized to.

  4. The subject is able and willing to wear provided frames and lenses (spectacles), foran 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 10years old (inclusive).

  6. Cycloplegic autorefraction spherical equivalent refraction (SER): -1.00 to -5.00 Din each eye at the screening visit.

  7. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye at thescreening visit.

  8. Cycloplegic spherical equivalent autorefraction (SER) anisometropia of 1.50 D orless at the screening visit.

  9. Monocular cycloplegic best corrected distance visual acuity (BCDVA) equal to orbetter than log MAR 0.10 in each eye at the screening visit.

Exclusion

Exclusion Criteria:

  1. Subjects with allergy to fluorescein, benoxinate, proparacaine, cyclopentolate ortropicamide eye drops.

  2. Subjects with ocular or systemic abnormalities that might be expected to affectvisual 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 singlevision contact lens prior to entry into the study or during the duration of thestudy.

  4. Subjects with, or a medical history of, strabismus.

  5. Subjects with a medical history of binocular vision abnormalities or accommodationabnormalities 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 entryinto 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 aninappropriate landscape for the intended study treatment.

  10. Subjects with pathological myopia (myopia that leads to structural changes in theposterior segment of the eye including posterior staphyloma, myopic maculopathy, andhigh myopia-associated optic neuropathy).

  11. Individuals from the same household (i.e., siblings), employees (or family membersof employees) of the Principal Investigator/site, employees (or family members ofemployees) of the Sponsor, and non-readers.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: DG1 Spectacle Lens
Phase:
Study Start date:
January 21, 2025
Estimated Completion Date:
January 31, 2030

Connect with a study center

  • Irvine Vision Center

    Irvine, California 92618
    United States

    Active - Recruiting

  • Columbia Eye Associates & Family Focus Eye Care

    Gainesville, Florida 32605
    United States

    Active - Recruiting

  • Coan Eye Care and Optical Boutique

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • Illinois College of Optometry

    Chicago, Illinois 60616
    United States

    Active - Recruiting

  • Complete Eye Care of Medina

    Medina, Minnesota 55340
    United States

    Active - Recruiting

  • Oculus Research, Inc.

    Garner, North Carolina 27529
    United States

    Active - Recruiting

  • ProCare Vision Centers, Inc.

    Granville, Ohio 43023
    United States

    Active - Recruiting

  • EyeCare Professionals of Powell

    Powell, Ohio 43065
    United States

    Active - Recruiting

  • Southern College of Optometry

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

  • Virginia Pediatric Eye Center

    Virginia Beach, Virginia 23452
    United States

    Active - Recruiting

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