Study of Atropine Therapeutic Effect on Myopic Progression (STAMP)

LitePharmTech

Status and phase: Enrolling; Phase 3

Conditions: Myopia; Children

Treatments: Drug: Atropine Sulfate 02; Drug: Atropine Sulfate 01; Drug: Atropine Sulfate 03; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05529056

LPT-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 472 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No 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 -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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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472 participants in 4 patient groups, including a placebo group

Test Arm 1

Experimental group

Description:

LPTAT01

Treatment:

Drug: Atropine Sulfate 01

Test Arm 2

Experimental group

Description:

LPTAT02

Treatment:

Drug: Atropine Sulfate 02

Test Arm 3

Experimental group

Description:

LPTAT03

Treatment:

Drug: Atropine Sulfate 03

Reference Arm

Placebo Comparator group

Description:

LPTAT04

Treatment:

Drug: Placebo