ow-dose atropine eye drops for children with myopia in the United Kingdom

Phase 1

• Conditions: Myopia; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2017-004108-23-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 289

Inclusion Criteria

1.Age 6-12 years (at the time of consenting)
2.Myopia of -0.5D or greater (spherical equivalent refractive error) in both eyes
3.Best-corrected distance visual acuity (BCDVA) of 0.20 logMAR or better in both eyes

Are the trial subjects under 18? yes
Number of subjects for this age range: 289
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Children with other ocular morbidities
2.Myopia of -10D or greater in either eye
3.Astigmatism of 2D or higher in either eye
4.Amblyopia
5.Significant health problems that can compromise the ability to attend research visits or complete the trial
6.Other factors that may compromise the ability to attend the research appointments
7.Parents or children with poor understanding of the English language
8.Children enrolled in other interventional trials
9.Allergy or hypersensitivity to atropine or excipients

Study & Design

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