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Study of Atropine Therapeutic Effect on Myopic Progression (STAMP)

Primary Purpose

Myopia, Children

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atropine Sulfate 01
Atropine Sulfate 02
Atropine Sulfate 03
Placebo
Sponsored by
LitePharmTech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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 -6.0 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.

Sites / Locations

  • Pusan National University HospitalRecruiting
  • Inje University Busan Paik HospitalRecruiting
  • Kangwon National University HospitalRecruiting
  • Chungnam National University HospitalRecruiting
  • Chung-Ang University Gwang Myeong hospitalRecruiting
  • Gachon University Gil HospitalRecruiting
  • HanGil Eye HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Kim'S Eye HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul Asan Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • The Catholic University of Korea Seoul St. Mary's HospitalRecruiting
  • Ajou University HospitalRecruiting
  • Yongin Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Test Arm 1

Test Arm 2

Test Arm 3

Reference Arm

Arm Description

LPTAT01

LPTAT02

LPTAT03

LPTAT04

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in Axial length (mm)
Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline

Full Information

First Posted
August 10, 2022
Last Updated
February 21, 2023
Sponsor
LitePharmTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05529056
Brief Title
Study of Atropine Therapeutic Effect on Myopic Progression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LitePharmTech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
472 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test Arm 1
Arm Type
Experimental
Arm Description
LPTAT01
Arm Title
Test Arm 2
Arm Type
Experimental
Arm Description
LPTAT02
Arm Title
Test Arm 3
Arm Type
Experimental
Arm Description
LPTAT03
Arm Title
Reference Arm
Arm Type
Placebo Comparator
Arm Description
LPTAT04
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate 01
Other Intervention Name(s)
LPTAT01
Intervention Description
Atropine sulfate 01 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate 02
Other Intervention Name(s)
LPTAT02
Intervention Description
Atropine sulfate 02 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate 03
Other Intervention Name(s)
LPTAT03
Intervention Description
Atropine sulfate 03 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
LPTAT04
Intervention Description
Placebo ophthalmic solution
Primary Outcome Measure Information:
Title
Change in Spherical Equivalent over 12-month
Description
Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Spherical Equivalent
Description
Change in spherical equivalent measured by cycloplegic autorefraction at 4, 8 months after administration of clinical trial drug compared to baseline
Time Frame
4, 8 months
Title
Change in Axial length (mm)
Description
Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline
Time Frame
4, 8, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GH KIM
Phone
82-70-8805-9682
Email
ghkim@litepharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sei Yeul Oh
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Choi
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moon
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoo
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee
Facility Name
Chung-Ang University Gwang Myeong hospital
City
Gwangmyeong
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paik
Facility Name
HanGil Eye Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang
Facility Name
Kim'S Eye Hospital
City
Seoul
ZIP/Postal Code
07301
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baek
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oh
Facility Name
Seoul Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shin
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung
Facility Name
Yongin Severance Hospital
City
Yongin
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seo

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Atropine Therapeutic Effect on Myopic Progression

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