Efficacy of IVMED-85 on Pediatric Myopia
ConditionMyopia, Progressive
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age5-16
SponsoriVeena Delivery Systems, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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 D
Best corrected distance visual acuity better than or equal to Snellen 20/40 (logMAR equivalent 0.3) in both eyes
Kmax >40 D and <50 D in both eyes
Disqualifiers
Current or previous myopia treatment with atropine, pirenzepine, or other topical anti-muscarinic
Significant central corneal scarring or hydrops
Known copper allergy
Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of screening
Trial design
Treatments tested in this trial
- IVMED 85
- Placebo
Treatment groups
216 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov