Study of Atropine Therapeutic Effect on Myopic Progression

Last updated: February 21, 2023
Sponsor: LitePharmTech Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Myopia

Treatment

N/A

Clinical Study ID

NCT05529056
LPT-01
  • Ages 5-12
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 asmeasured 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
  • Written informed consent willingly obtained by both subject and his/her parents

Exclusion

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 ofglaucoma, macula r degeneration, diabetic eye disease, uveitis, etc, or presence ofconjunctivitis 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 difficultiesin 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-monthprior to current IP administration.
  • Based on the investigator's discretion, subject who is not proper to participate inthe trial.

Study Design

Total Participants: 472
Study Start date:
May 25, 2022
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Inje University Busan Paik Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Kangwon National University Hospital

    Chuncheon,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Gwang Myeong hospital

    Gwangmyeong,
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Hospital

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • HanGil Eye Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si,
    Korea, Republic of

    Active - Recruiting

  • Kim'S Eye Hospital

    Seoul, 07301
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

  • Yongin Severance Hospital

    Yongin,
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.