Publication details
Zpráva o průběhu klinického hodnocení MARS (30. prosinec 2022 – 28. červen 2023)
| Title in English | MARS Clinical Trial Progress Report (December 30, 2022 - June 28, 2023) |
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| Authors | |
| Year of publication | 2023 |
| MU Faculty or unit | |
| web | MARS |
| Description | The primary outcome of the clinical evaluation is to determine the difference in the axial length of the eye (AXL) during the 12M application period when applying 0.02% atropine versus placebo. Semi-Annual report describes the progress of the clinical trial so far. The report includes information on the submission of initial clinical trial authorization applications to the regulatory authority and ethics committees and subsequent submission of document updates for approval. The report also provides information on the start of recruitment, the number of enrolled patients, the number of prematurely terminated patients, identified protocol violations, newly known information relevant for the safety and efficacy of the investigational medicinal product and also confirms that newly adopted measures (e.g. interventions by ethics committees , regulatory authority, possible restrictive interventions by the contracting authority or audits) were not required. |