Study of Atropine Therapeutic Effect on Myopic Progression
NCT ID: NCT05529056
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
472 participants
INTERVENTIONAL
2022-05-25
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test Arm 1
LPTAT01
Atropine Sulfate 01
Atropine sulfate 01 ophthalmic solution
Test Arm 2
LPTAT02
Atropine Sulfate 02
Atropine sulfate 02 ophthalmic solution
Test Arm 3
LPTAT03
Atropine Sulfate 03
Atropine sulfate 03 ophthalmic solution
Reference Arm
LPTAT04
Placebo
Placebo ophthalmic solution
Interventions
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Atropine Sulfate 01
Atropine sulfate 01 ophthalmic solution
Atropine Sulfate 02
Atropine sulfate 02 ophthalmic solution
Atropine Sulfate 03
Atropine sulfate 03 ophthalmic solution
Placebo
Placebo ophthalmic solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Years
12 Years
ALL
No
Sponsors
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LitePharmTech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sei Yeul Oh
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Pusan National University Hospital
Busan, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chung-Ang University Gwang Myeong hospital
Gwangmyeong, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
HanGil Eye Hospital
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Kim'S Eye Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Yongin Severance Hospital
Yŏngin, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Choi
Role: primary
Moon
Role: primary
Yoo
Role: primary
Lee
Role: primary
Kim
Role: primary
Paik
Role: primary
Kim
Role: primary
Yang
Role: primary
Baek
Role: primary
Oh
Role: primary
Lee
Role: primary
Kim
Role: primary
Shin
Role: primary
Chung
Role: primary
Seo
Role: primary
Other Identifiers
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LPT-01
Identifier Type: -
Identifier Source: org_study_id
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