Myopia, Progressive
Conditions
Brief summary
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 acuity * Does IVMED 85 slow or otherwise change the progression of myopia Participants will use eyedrops twice a day for one year. Researchers will compare IVMED 85 to a placebo.
Interventions
DRUGIVMED 85
Eye drop
DRUGPlacebo
Placebo eye drop
Sponsors
iVeena Delivery Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* To be considered for enrollment in the study, the patient must meet all of the following criteria: 1. 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). 2. Refractive error by cycloplegic refraction in both eyes: myopia -0.75 D to -9.75 D spherical equivalent; astigmatism ≤ 4.00D; anisometropia \<3.00 D 3. Best corrected distance visual acuity better than or equal to Snellen 20/40 (logMAR equivalent 0.3) in both eyes 4. Kmax \>40 D and \<50 D in both eyes 5. Minimum corneal thickness \> 350 microns in both eyes 6. Absence 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 eyes 7. Written informed consent from a parent or legal guardian and assent from participant 8. Willing 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: 1. Current or previous myopia treatment with atropine, pirenzepine, or other topical anti-muscarinic 2. Significant central corneal scarring or hydrops 3. Known copper allergy 4. Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of screening 5. Previous cornea, glaucoma, eyelid, strabismus (exotropia or esotropia) or intraocular surgeries 6. Prior 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) 7. Myopic degeneration with potential visual acuity worse than Snellen 20/40 (logMAR equivalent 0.3) 8. Intraocular pressure \>26 mmHg 9. Medical 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) 10. Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1 11. Employees of the study site or their immediate families 12. Pregnancy 13. Hypothyroidism or hyperthyroidism 14. Patient less than 17 Kg weight 15. Planned ophthalmic surgery during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 Efficacy - Change/Progression of myopic refractive error | Baseline compared to month 12 | Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye |
| Phase 1 Safety - Change in Best corrected distance visual acuity | Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days) | Best corrected distance visual acuity in the Study Eye |
| Phase 1 Safety - Change in Development of corneal scarring | Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days) | Development of corneal scarring in the study eye |
| Phase 1 Safety - Change in Patient assessment of comfort | Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days) | Patient assessment of burning, redness, discomfort, irritation in the study eye |
| Phase 1 Safety - Change in Tyroid enzyme levels | Baseline compared to week 4 | Thyroid enzyme levels |
| Phase 1 Safety - Change in Copper serum levels | Baseline compared to week 4 | Copper serum levels |
| Phase 2 Safety - Change in Best corrected distance visual acuity | Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) | Best corrected distance visual acuity in the Study Eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 Safety - Change in Patient assessment of comfort | Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) | Patient assessment of burning, redness, discomfort, irritation in the study eye |
| Phase 2 Efficacy - Change in keratometry | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days) | Measure keratometry in the Study Eye |
| Phase 2 Efficacy - Change in Axial length | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days) | Axial Length in the Study Eye |
| Phase 2 Efficacy - Change in Vitreous chamber depth | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days) | Vitreous chamber depth in the Study Eye |
| Phase 2 Efficacy - Intermediate change/progression of myopic refractive error | Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9 (+21 days) | Change/Progression of myopic refractive error (spherical equivalent as determined by cycloplegic refraction) in the Study Eye |
| Phase 2 Safety - Change in Development of corneal scarring | Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days) | Development of corneal scarring in the study eye |
Contacts
Primary ContactSarah Molokhia, RPH, PhD
Outcome results
None listed