Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058693) titled 'Post-hoc analysis of Myopia progression after discontinuation of Atropine sulfate (DE-127) ophthalmic solution in the Phase II/III clinical trial in Japan' on Aug. 4.
Study Type:
Others,meta-analysis etc
Primary Sponsor:
Institute - Santen Pharmaceutical Co., Ltd.
Condition:
Condition - Myopia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Using data of subjects that continued to treatment period II in Atropine sulfate (DE-127) ophthalmic solution in the Phase II/III clinical trial in Japan, we will examine the changes in cycloplegic objective spherical equivalent (SE) and axial length (AL) after switching from 0.01% or 0.025% DE-127 ophthalmic solution to placebo ophthalmic solution, as well as demographic and other factors that may influence these changes.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - None
Key exclusion criteria - None
Target Size - 211
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 08 Day
Date of IRB - 2025 Year 07 Month 23 Day
Anticipated trial start date - 2025 Year 08 Month 04 Day
Last follow-up date - 2025 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067087
Disclaimer: Curated by HT Syndication.
