TLG-001J Confirmatory Clinical Trial
Not Applicable
- Conditions
- Myopia
- Registration Number
- JPRN-jRCT2032220217
- Lead Sponsor
- Tsubota Kazuo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion 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
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in cycloplegic objective refraction: SE at Month 12 of investigational device use
- Secondary Outcome Measures
Name Time Method Changes from baseline in axial length at Months 1, 3, 6, 9, and 12 of device use, and others