A Phase 3 interventional study of Atropine Sulfate 01 and Atropine Sulfate 02 in Myopia and Children, sponsored by LitePharmTech Co., Ltd.. Status unknown at 15 sites in Korea, Republic of. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by LitePharmTech Co., Ltd. · Phase 3, Interventional, and Treatment
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 472 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →This is the only study on the registry with LitePharmTech Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LPTAT01
Drug: Atropine Sulfate 01
LPTAT02
Drug: Atropine Sulfate 02
LPTAT03
Drug: Atropine Sulfate 03
LPTAT04
Drug: Placebo
Atropine sulfate 01 ophthalmic solution
Also known as: LPTAT01
Atropine sulfate 02 ophthalmic solution
Also known as: LPTAT02
Atropine sulfate 03 ophthalmic solution
Also known as: LPTAT03
Placebo ophthalmic solution
Also known as: LPTAT04
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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