CClinicalTrials.gg
Status unknownNCT05529056STAMPUpdated Feb 23, 2023

Study of Atropine Therapeutic Effect on Myopic Progression

A Phase 3 interventional study of Atropine Sulfate 01 and Atropine Sulfate 02 in Myopia and Children, sponsored by LitePharmTech Co., Ltd.. Status unknown at 15 sites in Korea, Republic of. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by LitePharmTech Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
472
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Myopia
  • Children

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 472 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

This is the only study on the registry with LitePharmTech Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
472 participants (estimated)

Study arms

  • Experimental
    Test Arm 1

    LPTAT01

    Drug: Atropine Sulfate 01

  • Experimental
    Test Arm 2

    LPTAT02

    Drug: Atropine Sulfate 02

  • Experimental
    Test Arm 3

    LPTAT03

    Drug: Atropine Sulfate 03

  • Placebo comparator
    Reference Arm

    LPTAT04

    Drug: Placebo

Interventions

  • DrugAtropine Sulfate 01

    Atropine sulfate 01 ophthalmic solution

    Also known as: LPTAT01

  • DrugAtropine Sulfate 02

    Atropine sulfate 02 ophthalmic solution

    Also known as: LPTAT02

  • DrugAtropine Sulfate 03

    Atropine sulfate 03 ophthalmic solution

    Also known as: LPTAT03

  • DrugPlacebo

    Placebo ophthalmic solution

    Also known as: LPTAT04

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 4, 8 months

  2. Change in Axial length (mm)

    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

07

Study locations

15 of 15 sites recruiting
  • Pusan National University Hospital
    Busan, 49241, Korea, Republic of
    • Choi · Contact
    Recruiting
  • Inje University Busan Paik Hospital
    Busan, Korea, Republic of
    • Moon · Contact
    Recruiting
  • Kangwon National University Hospital
    Chuncheon, Korea, Republic of
    • Yoo · Contact
    Recruiting
  • Chungnam National University Hospital
    Daejeon, Korea, Republic of
    • Lee · Contact
    Recruiting
  • Chung-Ang University Gwang Myeong hospital
    Gwangmyeong, Korea, Republic of
    • Kim · Contact
    Recruiting
  • Gachon University Gil Hospital
    Incheon, 21565, Korea, Republic of
    • Paik · Contact
    Recruiting
  • HanGil Eye Hospital
    Incheon, Korea, Republic of
    • Kim · Contact
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Korea, Republic of
    • Yang · Contact
    Recruiting
  • Kim'S Eye Hospital
    Seoul, 07301, Korea, Republic of
    • Baek · Contact
    Recruiting
  • Samsung Medical Center
    Seoul, Korea, Republic of
    • Oh · Contact
    Recruiting
  • Seoul Asan Medical Center
    Seoul, Korea, Republic of
    • Lee · Contact
    Recruiting
  • Seoul National University Hospital
    Seoul, Korea, Republic of
    • Kim · Contact
    Recruiting
  • The Catholic University of Korea Seoul St. Mary's Hospital
    Seoul, Korea, Republic of
    • Shin · Contact
    Recruiting
  • Ajou University Hospital
    Suwon, Korea, Republic of
    • Chung · Contact
    Recruiting
  • Yongin Severance Hospital
    Yongin, Korea, Republic of
    • Seo · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05529056
Lead sponsor
LitePharmTech Co., Ltd.
Responsible party
Sponsor
First posted
Sep 6, 2022
Start date
May 25, 2022
Primary completion
Jun 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Feb 23, 2023

Study contacts

GH KIM
Contact
ghkim@litepharm.com
82-70-8805-9682
Sei Yeul Oh
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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