Study of Atropine Therapeutic Effect on Myopic Progression (STAMP)

February 21, 2023 updated by: LitePharmTech Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

472

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Choi
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • Moon
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Kangwon National University Hospital
        • Contact:
          • Yoo
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • Lee
      • Gwangmyeong, Korea, Republic of
        • Recruiting
        • Chung-Ang University Gwang Myeong Hospital
        • Contact:
          • Kim
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Hospital
        • Contact:
          • Paik
      • Incheon, Korea, Republic of
        • Recruiting
        • Hangil Eye Hospital
        • Contact:
          • Kim
      • Seongnam-si, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Yang
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Oh
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea Seoul St. Mary's Hospital
        • Contact:
          • Shin
      • Seoul, Korea, Republic of, 07301
        • Recruiting
        • Kim's Eye Hospital
        • Contact:
          • Baek
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul ASAN Medical Center
        • Contact:
          • Lee
      • Suwon, Korea, Republic of
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Chung
      • Yongin, Korea, Republic of
        • Recruiting
        • Yongin Severance Hospital
        • Contact:
          • Seo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Arm 1
LPTAT01
Drug: Atropine Sulfate 01
Atropine sulfate 01 ophthalmic solution
Other Names:
  • LPTAT01
Experimental: Test Arm 2
LPTAT02
Drug: Atropine Sulfate 02
Atropine sulfate 02 ophthalmic solution
Other Names:
  • LPTAT02
Experimental: Test Arm 3
LPTAT03
Drug: Atropine Sulfate 03
Atropine sulfate 03 ophthalmic solution
Other Names:
  • LPTAT03
Placebo Comparator: Reference Arm
LPTAT04
Drug: Placebo
Placebo ophthalmic solution
Other Names:
  • LPTAT04

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Spherical Equivalent over 12-month
Time Frame: 12 months
Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Spherical Equivalent
Time Frame: 4, 8 months
Change in spherical equivalent measured by cycloplegic autorefraction at 4, 8 months after administration of clinical trial drug compared to baseline
4, 8 months
Change in Axial length (mm)
Time Frame: 4, 8, 12 months
Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline
4, 8, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LitePharmTech Co., Ltd.

Investigators

  • Principal Investigator: Sei Yeul Oh, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe