Study of Atropine Therapeutic Effect on Myopic Progression

Myopia Clinical Trial

— STAMP  

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Therapeutic Effect and Safety of LPTAT in Children With Myopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529056
• Other study ID #: LPT-01
• Status: Recruiting
• Phase: Phase 3
• Start date: May 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: LitePharmTech Co., Ltd.
• Contact: GH KIM
• Phone: 82-70-8805-9682
• Email: ghkim[@]litepharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 472
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Myopia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chung-Ang University Gwang Myeong hospital	Gwangmyeong
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	HanGil Eye Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Kim'S Eye Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Yongin Severance Hospital	Yongin

Sponsors (1)

Lead Sponsor	Collaborator
LitePharmTech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Spherical Equivalent over 12-month	Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline	12 months
Secondary	Change in Spherical Equivalent	Change in spherical equivalent measured by cycloplegic autorefraction at 4, 8 months after administration of clinical trial drug compared to baseline	4, 8 months
Secondary	Change in Axial length (mm)	Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline	4, 8, 12 months