Myopia
Conditions
Interventions
0.4% GPN00884 group:0.4% GPN00884
0.8%GPN00884 group:0.8%GPN00884
Placebo group (Phase I):Placebo
GPN00884 Dose Group (Phase II):GPN00884 Eye Drops
Placebo group (Phase II):Placebo
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age between 6 years and 12 years, no gender restriction; 2. After ciliary muscle paralysis, the equivalent spherical degree of both eyes measured by computer optometry is between -0.50D and -3.00D; 3. After ciliary muscle paralysis, the astigmatism of both eyes measured by computer optometry is <= 1.50D; 4. The difference in refraction between both eyes (measured by equivalent spherical degree) is <= 1.50D; 5. The far vision of either eye can be corrected to logMAR vision of 4.9 or above; 6. Informed consent signed by the child and the legal guardian has been obtained.
Exclusion criteria
Exclusion criteria: 1. Allergic to any component of the study medication; 2. Subjects with a history of severe systemic diseases; 3. History of manifest strabismus, amblyopia, extraocular muscle movement disorders, or other pathological changes in the eyeball in either eye; 4. History of ocular conditions affecting vision or refractive status in either eye; 5. History of chronic ocular inflammation or recurrent episodes of ocular inflammation in either eye; 6. Diseases in either eye affecting corneal curvature, such as entropion, ectropion, ptosis, or incomplete eyelid closure; 7. At screening, intraocular pressure in either eye > 21 mmHg or interocular pressure difference > 5 mmHg; 8. History of intraocular surgery, strabismus surgery, or ocular surgeries or laser treatments affecting refractive media or refractive power in either eye; 9. Previously used or planned to use any myopia control treatment other than the study medication during the trial; 10. Used traditional Chinese medicine, ear acupuncture, massage, or auricular points therapies to control myopia progression within 30 days prior to screening; 11. Participated in any other drug or device clinical trials and used clinical trial drugs or devices within 3 months prior to screening; 12. Other conditions that the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spherical Equivalent Refraction; | — |
Countries
China
Contacts
Public ContactXiao Yang
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed