Phase
Condition
Myopia
Treatment
N/AClinical Study ID
Ages 5-12 All Genders
Study Summary
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
Study Description
Connect with a study center
Inje University Busan Paik Hospital
Busan,
Korea, Republic ofActive - Recruiting
Pusan National University Hospital
Busan, 49241
Korea, Republic ofActive - Recruiting
Kangwon National University Hospital
Chuncheon,
Korea, Republic ofActive - Recruiting
Chungnam National University Hospital
Daejeon,
Korea, Republic ofActive - Recruiting
Chung-Ang University Gwang Myeong hospital
Gwangmyeong,
Korea, Republic ofActive - Recruiting
Gachon University Gil Hospital
Incheon, 21565
Korea, Republic ofActive - Recruiting
HanGil Eye Hospital
Incheon,
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam-si,
Korea, Republic ofActive - Recruiting
Kim'S Eye Hospital
Seoul, 07301
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon,
Korea, Republic ofActive - Recruiting
Yongin Severance Hospital
Yongin,
Korea, Republic ofActive - Recruiting
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