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

Primary Purpose

Myopia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Model-A Novel spectacle lens
Model-B Novel spectacle lens
Single vision spectacle lens
Sponsored by
HOYA Lens Thailand LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participant and parent (or guardian) are able and willing to provide consent Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study Age at time of parent or guardian consent and participant assent: 8 - 13 years old Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye Cycloplegic autorefraction anisometropia of 1.50 D or less Monocular best corrected distance visual acuity (BCDVA) equal to or better than logMAR 0.00 in each eye. Exclusion Criteria: Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development Have received treatment of myopic control (e.g., orthokeratology, progressive addition lenses, bifocal lenses, medication (e.g., atropine), etc. within 6 months prior to entry into this study. Participant with clinically significant strabismus (including intermittent tropia) Medical history of binocular vision abnormalities Participant with amblyopia Participation in a clinical trial within 30 days prior to entry into this study or during participation Previous intraocular surgery Participant who, in the judgment of the Investigator, presence of any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment. Any medical treatment or medication which might have an influence on vision or interfere with study assessments 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)

Sites / Locations

  • Beijing Tongren Hospital, Capital Medical UniversityRecruiting
  • Guangzhou Aier Eye HospitalRecruiting
  • Tianjin Medical University Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Model-A Novel Spectacle lens

Model-B Novel Spectacle lens

Single Vision Spectacle lens

Arm Description

Outcomes

Primary Outcome Measures

Axial length
The difference of Axial length changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants.
Spherical equivalent cycloplegic autorefraction
The difference of spherical equivalent cycloplegic autorefraction changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants

Secondary Outcome Measures

Axial length
Spherical equivalent cycloplegic autorefraction

Full Information

First Posted
May 23, 2023
Last Updated
October 20, 2023
Sponsor
HOYA Lens Thailand LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT05886348
Brief Title
The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens
Official Title
The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HOYA Lens Thailand LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
285 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Model-A Novel Spectacle lens
Arm Type
Experimental
Arm Title
Model-B Novel Spectacle lens
Arm Type
Experimental
Arm Title
Single Vision Spectacle lens
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Model-A Novel spectacle lens
Intervention Description
Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months
Intervention Type
Device
Intervention Name(s)
Model-B Novel spectacle lens
Intervention Description
Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months
Intervention Type
Device
Intervention Name(s)
Single vision spectacle lens
Intervention Description
Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months
Primary Outcome Measure Information:
Title
Axial length
Description
The difference of Axial length changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants.
Time Frame
24 months
Title
Spherical equivalent cycloplegic autorefraction
Description
The difference of spherical equivalent cycloplegic autorefraction changes over 24 months between treatment groups in low and moderate myopia (-1.00 D to -5.00 D) participants
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Axial length
Time Frame
36 months
Title
Spherical equivalent cycloplegic autorefraction
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant and parent (or guardian) are able and willing to provide consent Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study Age at time of parent or guardian consent and participant assent: 8 - 13 years old Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye Cycloplegic autorefraction anisometropia of 1.50 D or less Monocular best corrected distance visual acuity (BCDVA) equal to or better than logMAR 0.00 in each eye. Exclusion Criteria: Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development Have received treatment of myopic control (e.g., orthokeratology, progressive addition lenses, bifocal lenses, medication (e.g., atropine), etc. within 6 months prior to entry into this study. Participant with clinically significant strabismus (including intermittent tropia) Medical history of binocular vision abnormalities Participant with amblyopia Participation in a clinical trial within 30 days prior to entry into this study or during participation Previous intraocular surgery Participant who, in the judgment of the Investigator, presence of any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment. Any medical treatment or medication which might have an influence on vision or interfere with study assessments 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TRD Clinical Trial Manager, Japan
Phone
042-519-4251
Email
v-clin-aff@hoya.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Zhou, MD
Organizational Affiliation
HOYA Lens Thailand LTD.
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Dongcheng
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central contact
Facility Name
Guangzhou Aier Eye Hospital
City
Yuexiu
State/Province
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central contact
Facility Name
Tianjin Medical University Eye Hospital
City
Nankai
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central contact

12. IPD Sharing Statement

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

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