The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens

Last updated: July 23, 2024
Sponsor: HOYA Lens Thailand LTD.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Myopia

Treatment

Model-B Novel spectacle lens

Model-A Novel spectacle lens

Single vision spectacle lens

Clinical Study ID

NCT05886348
DG2-3A
  • Ages 7-13
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant and parent (or guardian) are able and willing to provide consent

  2. Participant and parent (or guardian) ensure to attend required study visits andadhere to participant requirements

  3. Parent or guardian understands and accepts random allocation of grouping, and thatparticipant and parent (or guardian) will not be told which group participant isallocated to

  4. Participant willing to wear the study spectacles lens for a minimum of 12 hours perday for the duration of the study

  5. Age at time of parent or guardian consent and participant assent: 7 - 13 years old

  6. Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye.

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

  8. Cycloplegic autorefraction anisometropia of 1.50 D or less

  9. Monocular best corrected distance visual acuity (BCDVA) equal to or better thanlogMAR 0.00 in each eye.

Exclusion

Exclusion Criteria:

  1. Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide orcyclopentolate eye drops

  2. Any ocular and systemic abnormalities might be expected to affect visual functionsor refractive development

  3. (a) Have received treatment of myopic control pharmaceutical medication (e.g.,atropine) or light fundus illuminance therapy (e.g., repeated red light therapy)within 6 months prior to entry into this study. (b) Have received treatment ofmyopia control such as contact lenses, orthokeratology lenses etc., progressiveaddition lenses, bifocal lenses, within 3 months. (c) Have received treatment ofmyopia control such as defocus spectacle lenses (difference between both eye'snon-cycloplegic autorefraction and lens-meter results of the respective lenses areequal or less than 0.50 D SER) etc. within one month prior to entry into this study.

  4. Participant with clinically significant strabismus (including intermittent tropia)

  5. Medical history of binocular vision abnormalities

  6. Participant with amblyopia

  7. Participation in a clinical trial within 30 days prior to entry into this study orduring participation

  8. Previous intraocular surgery

  9. Participant who, in the judgment of the Investigator, presence of any emotional,physiologic, or anatomical condition which may preclude participation in this studyor provide an inappropriate landscape for the intended study treatment.

  10. Any medical treatment or medication which might have an influence on vision orinterfere with study assessments

  11. Pathological myopia (myopia that leads to structural changes in the posteriorsegment of the eye including posterior staphyloma, myopic maculopathy, and highmyopia-associated optic neuropathy)

Study Design

Total Participants: 249
Treatment Group(s): 4
Primary Treatment: Model-B Novel spectacle lens
Phase:
Study Start date:
July 31, 2023
Estimated Completion Date:
May 31, 2027

Study Description

This is a 3-year prospective, multicenter, randomized, and single-masked*, parallel-group controlled clinical study. The purpose of this study is to evaluate the safety and efficacy of wearing Novel spectacle lenses to correct myopic ametropia, slow the progression of myopia and axial elongation in myopic children as compared to the use of single vision spectacles lenses.

The treatment arms are:

  • Model A Novel spectacle lens

  • Model B Novel spectacle lens

  • Single vision spectacle lens

Single-masked:

The investigator responsible for conducting ocular data measurements related to the primary and secondary endpoints will be masked. The participants will not be informed the treatment arm during the clinical trial.

Connect with a study center

  • Beijing Tongren Hospital, Capital Medical University

    Dongcheng, Beijing
    China

    Site Not Available

  • Guangzhou Aier Eye Hospital

    Yuexiu, Guangzhou
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Nankai, Tianjin
    China

    Site Not Available

  • Beijing Tongren Hospital, Capital Medical University

    Beijing,
    China

    Site Not Available

  • Guangzhou Aier Eye Hospital

    Guangzhou,
    China

    Site Not Available

  • Eye and ENT Hospital of Fudan University

    Shanghai,
    China

    Site Not Available

  • Shengyang He Eye Specialist Hospital

    Shengyang,
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin,
    China

    Site Not Available

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