TLG-001J Confirmatory Clinical Trial

JRCT ID: jRCT2032220217

Registered date:16/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Myopia
• Date of first enrollment: 09/07/2022
• Target sample size: 160
• Study type: Interventional
• Intervention(s): The subjects will be assigned randomly to the trial device or control device at a 1:1 ratio and wear the assigned device every day for 12 months. This will be followed by 12-month follow-up period without wearing the device. There will be 9 visits in total during these 24 months.

Outcome(s)

• Primary Outcome: Change from baseline in cycloplegic objective refraction: SE at Month 12 of investigational device use
• Secondary Outcome: Changes from baseline in axial length at Months 1, 3, 6, 9, and 12 of device use, and others

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 12age old
• Gender: Both

Include criteria

- Male and female Japanese schoolchildren who are 6 to 12 years old at the time of informed consent
- Anisometropia is within 1.50 D
- Astigmatism, cycloplegic objective refraction (C), is within +/- 1.50 D for each eye

Exclude criteria

- A history of refractive and/or other form of ophthalmic surgery
- Impaired binocular visual function
- Amblyopia or manifest strabismus
- Individuals who are likely to require contact lenses (e.g., monofocal, bifocal, orthokeratology) or multifocal eyeglasses during the trial

Related Information

• Primary Sponsor: Tsubota Kazuo
• Source(s) of Monetary Support: JINS HOLDINGS