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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886348
• Other study ID #: DG2-3A
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: August 2023
• Source: HOYA Lens Thailand LTD.
• Contact: TRD Clinical Trial Manager, Japan
• Phone: 042-519-4251
• Email: v-clin-aff[@]hoya.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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 and adhere to participant requirements

3. 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

4. Participant willing to wear the study spectacles lens for a minimum of 12 hours per day 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 than logMAR 0.00 in each eye.

Exclusion Criteria:

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

2. Any ocular and systemic abnormalities might be expected to affect visual functions or 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 of myopia control such as contact lenses, orthokeratology lenses etc., progressive addition lenses, bifocal lenses, within 3 months. (c) Have received treatment of myopia control such as defocus spectacle lenses (difference between both eye's non-cycloplegic autorefraction and lens-meter results of the respective lenses are equal 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 or during 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 study or provide an inappropriate landscape for the intended study treatment.

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

11. 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)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Model-A Novel spectacle lens
Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months
• Model-B Novel spectacle lens
Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months
• Single vision spectacle lens
Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months

Locations

Country	Name	City	State
China	Beijing Tongren Hospital, Capital Medical University	Dongcheng	Beijing
China	Tianjin Medical University Eye Hospital	Nankai	Tianjin
China	Shengyang He Eye Specialist Hospital	Shengyang	Liaoning
China	Guangzhou Aier Eye Hospital	Yuexiu	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
HOYA Lens Thailand LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Primary	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	24 months
Secondary	Axial length		36 months
Secondary	Spherical equivalent cycloplegic autorefraction		36 months