This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.
The primary objective is to evaluate the superiority of LPTAT to placebo in slowing myopia progression through the change of SE(Spherical Equivalent), which is measured by cycloplegic autorefraction after 12-month treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
472
Atropine sulfate 01 ophthalmic solution
Atropine sulfate 02 ophthalmic solution
Atropine sulfate 03 ophthalmic solution
Pusan National University Hospital
Busan, South Korea
RECRUITINGInje University Busan Paik Hospital
Busan, South Korea
Change in Spherical Equivalent over 12-month
Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline
Time frame: 12 months
Change in Spherical Equivalent
Change in spherical equivalent measured by cycloplegic autorefraction at 4, 8 months after administration of clinical trial drug compared to baseline
Time frame: 4, 8 months
Change in Axial length (mm)
Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline
Time frame: 4, 8, 12 months
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Placebo ophthalmic solution
Kangwon National University Hospital
Chuncheon, South Korea
RECRUITINGChungnam National University Hospital
Daejeon, South Korea
RECRUITINGChung-Ang University Gwang Myeong hospital
Gwangmyeong, South Korea
RECRUITINGGachon University Gil Hospital
Incheon, South Korea
RECRUITINGHanGil Eye Hospital
Incheon, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam-si, South Korea
RECRUITINGKim'S Eye Hospital
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITING...and 5 more locations