Trials / Unknown
UnknownNCT05529056
Study of Atropine Therapeutic Effect on Myopic Progression
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Therapeutic Effect and Safety of LPTAT in Children With Myopia
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 472 (estimated)
- Sponsor
- LitePharmTech Co., Ltd. · Industry
- Sex
- All
- Age
- 5 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atropine Sulfate 01 | Atropine sulfate 01 ophthalmic solution |
| DRUG | Atropine Sulfate 02 | Atropine sulfate 02 ophthalmic solution |
| DRUG | Atropine Sulfate 03 | Atropine sulfate 03 ophthalmic solution |
| DRUG | Placebo | Placebo ophthalmic solution |
Timeline
- Start date
- 2022-05-25
- Primary completion
- 2023-06-30
- Completion
- 2023-12-31
- First posted
- 2022-09-06
- Last updated
- 2023-02-23
Locations
15 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05529056. Inclusion in this directory is not an endorsement.