Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-03 @ 2:22 AM
Study NCT ID:
NCT01455233
Status:
COMPLETED
Last Update Posted:
2011-10-19
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
Sponsor:
Ophthalmology Consultants, Ltd.
Organization:
Study Overview
Official Title:
Phase IV Study: A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance Versus Vigamox Prophylactically Pre and Post Operatively in Subjects Undergoing Routine Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
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:
STB-01
Brief Summary:
The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.
Detailed Description:
Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively.
Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
Study Oversight
Has Oversight DMC:
True
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?: