Preventing the progression of shortsightedness in children using an eye drop called Atropine

Phase 1

Active, not recruiting

Conditions: Myopia- a refractive error due to a discrepancy between the anatomical axial length and the focal length of the eye. resulting in distant objects appearing blurred
MedDRA version: 20.0Level: PTClassification code 10028651Term: MyopiaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2016-003340-37-IE

Lead Sponsor: Technological University Dublin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

To be eligible for inclusion, each child must have spherical equivalent refractive error of -1.0D or worsewith myopia progression of at least -0.50DS over the last year, based on refractive or clinical evidence. They must have astigmatism less than or equal to -2.50D and an intraocular difference in spherical equivalent <= 1D. Their corrected visual acuity must be better or equal to logMAR 0.2in both eyes and ifference between non-cycloplegic and cycloplegic spherical refraction of less than 1.00 D. Participants must have normal IOP (<= 21mmHg), normal ocular health and good general health with no history of cardiac/respiratory diseases. Participants must have willingness to commit to the 2 year clinical trial as well as randomisation to the placebo.
Are the trial subjects under 18? yes
Number of subjects for this age range: 250
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

Any child meeting any of the exclusion criteria at the baseline visit will be excluded from study participation:
•Ocular/systemic diseases/conditions affecting vision or refractive error
•Any ocular/systemic condition wherein atropine is contraindicated
•Known allergy to atropine, cyclopentolate hydrochloride and/or proxymetacaine hydrochloride
•Defective binocular vision, amblyopia or strabismus
•Any other conditions precluding adherence to the protocol including allergy to study eye drops (active agent or preservative)
•Previous pharmaceutical or optical myopia control interventions
•Subjects (or parent/guardian) unable to provide written informed consent Subjects (or parent/guardian) unable to provide written informed consent