Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371124
Status:
UNKNOWN
Last Update Posted:
2010-08-31
First Post:
2006-08-30
Brief Title:
Safety and Efficacy Study of 05 01 001 Atropine Treatment to Both Eyes In Treatment of Myopia In Children
Sponsor:
Singapore National Eye Centre
Organization:
Singapore National Eye Centre
Study Overview
Official Title:
A Randomised Double-Masked Study to Compare The Safety and Efficacy of Bilateral 05 01 001 Atropine Treatment In Controlling Progression of Myopia In Children
Status:
UNKNOWN
Status Verified Date:
2010-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy safety and functional impact of binocular treatment with 05 01 and 001 atropine and to develop a treatment regimen for the routine management of childhood myopia
Detailed Description:
A Randomised Double-Masked Study to Compare The Safety and Efficacy of Bilateral 05 01 001 Atropine Treatment In Controlling Progression of Myopia In Children
Study Duration and Visit Schedule Total of 5 years with 15 scheduled visits
1 Phase I 2 years with 8 scheduled visits
2 Phase II 3 years with 7 scheduled visits
STUDY DESIGN This study consists of 2 phases each with a different design Phase I is a double-masked single-centre clinical trial wherein 400 children aged 6-12 years with myopia of -200 D or worse in each eye and from whom assent and parentalguardian consent have been obtained will be randomised to receive 05 atropine 01 atropine or 001 atropine once nightly in both eyes Participants will be assigned to treatment in the ratio of 221 respectively Each child will receive treatment for a period of 2 years during which they will be reviewed every 4 months
Phase II is an open-label study wherein all children will continue to be followed-up regularly for changes in their refractive error after stopping atropine treatment Those children who demonstrate myopia progression of -05 D or more at least on one eye after a minimum of 8 months washout period will restart atropine treatment in both eyes The appropriate dose will be determined by analysis of the data from Phase I of the study Treatment will be for a further 2 years and all children including those not receiving treatment will be reviewed every 6 months
Study Duration and Visit Schedule Total of 5 years with 15 scheduled visits
1 Phase I 2 years with 8 scheduled visits
2 Phase II 3 years with 7 scheduled visits
STUDY DESIGN This study consists of 2 phases each with a different design Phase I is a double-masked single-centre clinical trial wherein 400 children aged 6-12 years with myopia of -200 D or worse in each eye and from whom assent and parentalguardian consent have been obtained will be randomised to receive 05 atropine 01 atropine or 001 atropine once nightly in both eyes Participants will be assigned to treatment in the ratio of 221 respectively Each child will receive treatment for a period of 2 years during which they will be reviewed every 4 months
Phase II is an open-label study wherein all children will continue to be followed-up regularly for changes in their refractive error after stopping atropine treatment Those children who demonstrate myopia progression of -05 D or more at least on one eye after a minimum of 8 months washout period will restart atropine treatment in both eyes The appropriate dose will be determined by analysis of the data from Phase I of the study Treatment will be for a further 2 years and all children including those not receiving treatment will be reviewed every 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None