Children, Myopia
Conditions
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.
Interventions
DRUGAtropine Sulfate 01
Atropine sulfate 01 ophthalmic solution
DRUGAtropine Sulfate 02
Atropine sulfate 02 ophthalmic solution
DRUGAtropine Sulfate 03
Atropine sulfate 03 ophthalmic solution
DRUGPlacebo
Placebo ophthalmic solution
Sponsors
LitePharmTech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spherical Equivalent over 12-month | 12 months | Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spherical Equivalent | 4, 8 months | 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) | 4, 8, 12 months | Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline |
Countries
South Korea
Contacts
Primary ContactGH KIM
Outcome results
None listed