Study of slowing progression (worsening) of school myopia (short-sightedness) in children by testing very low dose atropine eye drops against placebo eye drops (drops without atropine).

Phase 1

• Conditions: Myopia progression; MedDRA version: 20.0 Level: PT Classification code 10028651 Term: Myopia System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-001077-24-ES
• Lead Sponsor: evakar Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 483

Inclusion Criteria

1. Children (male or female) aged 3 to < or = 17.0 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.
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 overall between-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 Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Between-group difference in mean progression rates<br> 2. Between-group difference in proportion of subjects who show <-0.75 D progression and the between-group median time to a change in myopia of <-0.75 D<br> ;Timepoint(s) of evaluation of this end point: Month 12, Month 24, Month 36