Clinical trial NCT05529056: Study of Atropine Therapeutic Effect on Myopic Progression
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Therapeutic Effect and Safety of LPTAT in Children With Myopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myopia
Children
Lead sponsor: LitePharmTech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 472
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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 -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.

Primary outcomes:
measure: Change in Spherical Equivalent over 12-month
timeFrame: 12 months
Secondary outcomes:
measure: Change in Spherical Equivalent
timeFrame: 4, 8 months
measure: Change in Axial length (mm)
timeFrame: 4, 8, 12 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwang Myeong hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: HanGil Eye Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kim'S Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
affiliation: Samsung Medical Center
name: Sei Yeul Oh
role: PRINCIPAL_INVESTIGATOR
References: