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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
IVMED 85
DrugEye drop
Placebo
DrugPlacebo eye drop
Treatment groups
216 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: IVMED-85 Low Dose and placeboExperimental treatment 2 interventions
Group B: IVMED-85 Mid Dose and placeboExperimental treatment 2 interventions
Group C: IVMED-85 High Dose and placeboExperimental treatment 2 interventions
Group D: IVMED-85 Low DoseExperimental treatment 1 intervention
Group E: IVMED-85 Mid DoseExperimental treatment 1 intervention
Group F: IVMED-85 High DoseExperimental treatment 1 intervention
Group G: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1 Safety - Change in Best corrected distance visual acuity
Best corrected distance visual acuity in the Study Eye
Time frame
Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)2
Phase 1 Safety - Change in Development of corneal scarring
Development of corneal scarring in the study eye
Time frame
Baseline compared to Day 0, Weeks 1, 2 and 4 (+ 5 days)3
Phase 1 Safety - Change in Patient assessment of comfort
Patient assessment of burning, redness, discomfort, irritation in the study eye
Time frame
Baseline compared to Day 0, Weeks 1,2 and 4 (+ 5 days)4
Phase 1 Safety - Change in Tyroid enzyme levels
Thyroid enzyme levels
Time frame
Baseline compared to week 4Secondary outcomes
1
Phase 2 Safety - Change in Development of corneal scarring
Development of corneal scarring in the study eye
Time frame
Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)2
Phase 2 Safety - Change in Patient assessment of comfort
Patient assessment of burning, redness, discomfort, irritation in the study eye
Time frame
Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, and 12 (+ 21 days)3
Phase 2 Efficacy - Change in keratometry
Measure keratometry in the Study Eye
Time frame
Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)4
Phase 2 Efficacy - Change in Axial length
Axial Length in the Study Eye
Time frame
Baseline compared to Weeks 1 and 4 (+ 5 days) and Months 3, 6, 9, 12 (+21 days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: