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

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.

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.