Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263471
Status:
UNKNOWN
Last Update Posted:
2005-12-14
First Post:
2005-12-06
Brief Title:
Myopia Progression and the Effect of 7-Methylxanthine
Sponsor:
Trier Research Laboratories
Organization:
Trier Research Laboratories
Study Overview
Official Title:
Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia
Status:
UNKNOWN
Status Verified Date:
2003-10
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:
7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera Deficient collagen in the sclera may be the cause of progression of childhood myopia The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia
Detailed Description:
Participants are given tablets of 7-methylxanthine 400 mg per day or placebo tablets for 12 months Axial length cycloplegic refraction and corneal curvature is measured as well as weight height blood pressure and heart rate The participants are interviewed about possible CNS gastrointestinal or cardiopulmonal side effects
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