To treat the progression of myopia in children MedDRA version: 20.0 Level: PT Classification code 10028651 Term: Myopia System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Vyluma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children (male or female) aged 6 to = 10.0 years. 2. Myopia SER of at least -0.50 D and no greater than -6.00 D myopia in each eye as measured by cycloplegic autorefraction. 6. Distance vision correctable to at least 0.1 logMAR or 20/25 Snellen equivalent in each eye. Are the trial subjects under 18? yes Number of subjects for this age range: 483 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. If present, astigmatism more than -1.50 in either eye 2. Current or history of amblyopia or manifest strabismus. 3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity). 4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia). 5. Serious systemic illness that, in the Investigator’s opinion, would render the subject ineligible. 6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over-the-counter) other than the assigned study medication. 19. Current or history of significant or severe damage to the cornea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of 2 concentrations of Atropine Sulfate Ophthalmic Solution (0.01% and 0.02%) compared to Vehicle (placebo) for slowing the progression of myopia in children over a 3-year treatment period.;Secondary Objective: Exploratory: To observe safety and efficacy in subjects re-randomized to 1 year of treatment with Atropine Sulfate Ophthalmic Solution, 0.01% or 0.02%, or Vehicle following 3 years of treatment in children with progressive myopia.;Primary end point(s): The between-treatment group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit.;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Between-treatment group difference in the mean change from baseline in SER at the Month 36 visit. 2. Between-treatment group difference in the proportion of subjects who show < -0.50 D myopia progression (SER) from baseline at the Month 36 visit.;Timepoint(s) of evaluation of this end point: Month 12, Month 24, Month 36 | — |
Countries
Hungary, Ireland, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactSimon Chandler PhD
Vyluma Inc.
Outcome results
None listed