Study of Atropine Therapeutic Effect on Myopic Progression

Study Overview
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Brief Summary
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This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.

Detailed Description
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Therapeutic Effect and Safety of LPTAT in Children With Myopia

Conditions
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Myopia, Children

Intervention / Treatment
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* Drug: Atropine Sulfate 01
* Drug: Atropine Sulfate 02
* Drug: Atropine Sulfate 03
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 5 to 12 years at the time of consent Refractive error of SE at least -1.0 D and no greater than -8.0 D in both eyes as measured by cycloplegic autorefraction at visit 1 and visit 2. Confirmed myopia progression of 0.5D or more within past 1year Astigmatism of 2.5D or less in both eyes Distance Best Corrective Visual Acuity to logMAR 0.2 or better in both eyes at visit1. Normal IOP under 21mmHg in both eyes. Anisometropia of SE less than 2.0D as measured by cycloplegic autorefraction at visit 1. Written informed consent willingly obtained by both subject and his/her parents Exclusion Criteria: Hypersensitivity to atropine or other cycloplegic agent. History of the surgery of refractive correction Having ocular disease affect to visual function or refractive error: history of glaucoma, macula r degeneration, diabetic eye disease, uveitis, etc, or presence of conjunctivitis at screening visit. Having systemic diseases that affect to vision loss Having risk of IOP elevation such as narrow angle, Shallow Anterior Chambers, etc Presence of binocular function disorder or stereopsis disorder Amblyopia or manifest strabismus History of premature birth(less than 37weeks) or low birth weight(less than 2,500g) Previous or current use of atropine or Ortho-K lens for myopia Down syndrome, spastic paralysis, brain damage, spastic palsy, bladder Presence of neurological diseases like epilepsy, etc. which could expect difficulties in compliant to the ocular examinations. Presence of clinically significant cardiac and respiratory diseases Participation in any other clinical study of an investigational product within 3-month prior to current IP administration. Based on the investigator's discretion, subject who is not proper to participate in the trial.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Arm 1<br>LPTAT01 | Drug: Atropine Sulfate 01<br>* Atropine sulfate 01 ophthalmic solution<br>* Other names: LPTAT01;|
| Experimental: Test Arm 2<br>LPTAT02 | Drug: Atropine Sulfate 02<br>* Atropine sulfate 02 ophthalmic solution<br>* Other names: LPTAT02;|
| Experimental: Test Arm 3<br>LPTAT03 | Drug: Atropine Sulfate 03<br>* Atropine sulfate 03 ophthalmic solution<br>* Other names: LPTAT03;|
| Placebo Comparator: Reference Arm<br>LPTAT04 | Drug: Placebo<br>* Placebo ophthalmic solution<br>* Other names: LPTAT04;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 4, 8, 12 months |