STudy of Atropine Therapeutic Effect on Myopic Progression

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LitePharmTech Co., Ltd.
• Treatments: Atropine

Criteria

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 -6.0 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.