Efficacy of IVMED-85 on Pediatric Myopia

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric myopia by assessing its safety effects on visual acuity and its effect on the change and/or progression of myopia.The main question[s] it aims to answer are:Does IVMED 85 improve visual acuityDoes IVMED 85 slow or otherwise change the progression of myopiaParticipants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.

Inclusion Criteria:To be considered for enrollment in the study, the patient must meet all of the following criteria:Age 5 to 16 years and 6 months, three age groups cohorts (5-8), (9-12), and (13-16) (Phase 1 patients will be exclusively age 13-16).Refractive error by cycloplegic refraction in both eyes: myopia -0.75 D to -9.75 D spherical equivalent; astigmatism ≤ 4.00D; anisometropia <3.00 DBest corrected distance visual acuity better than or equal to Snellen 20/40 (logMAR equivalent 0.3) in both eyesKmax >40 D and <50 D in both eyesMinimum corneal thickness > 350 microns in both eyesAbsence of ocular comorbidities (glaucoma, cataract, anterior segment dysgenesis, corneal scarring, juvenile rheumatoid arthritis, lens subluxation, uveitis, collagen disorders (Ehlers-Danlos, Marfan's syndrome, osteogenesis imperfecta, retinal diseases) in both eyesWritten informed consent from a parent or legal guardian and assent from participantWilling and able to comply with clinic visits and study-related procedures.Exclusion Criteria:A patient who meets any of the following criteria, in either eye, will be excluded from the study:Current or previous myopia treatment with atropine, pirenzepine, or other topical anti-muscarinicSignificant central corneal scarring or hydropsKnown copper allergyUse of rigid gas permeable lenses, including orthokeratology lenses within 90 days of screeningPrevious cornea, glaucoma, eyelid, strabismus (exotropia or esotropia) or intraocular surgeriesPrior history of ocular disorder (e.g., current or prior history of strabismus (exotropia or esotropia), amblyopia, glaucoma, cataract, retinal detachment or nystagmus, or abnormality of the cornea, lens, iris, ciliary body, or central retina)Myopic degeneration with potential visual acuity worse than Snellen 20/40 (logMAR equivalent 0.3)Intraocular pressure >26 mmHgMedical conditions pre-disposing patient to degenerative myopia or abnormal ocular refractive anatomy (e.g., Stickler Syndrome, Down Syndrome, osteogenesis imperfecta, Ehler's-Danlos Syndrome, Retinopathy of Prematurity)Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1Employees of the study site or their immediate familiesPregnancyHypothyroidism or hyperthyroidismPatient less than 17 Kg weightPlanned ophthalmic surgery during the study