TLG-001J Confirmatory Clinical Trial

The requested reference [e375d7b6fff951315d44067ec2098953843c1076] no longer exists in our database. It has been replaced by the current reference: [457cfc1e6bc4d920a1a59ead4ce5f73cb4432476]

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2022
INTERVENTION: 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. CONDITION: Myopia 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 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
Epistemonikos ID: bd21a18a2719df1017376c259bba1104807078e5
First added on: Aug 26, 2024