Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366691
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2006-08-17
Brief Title:
Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Comparison of Acular LS With Lotemax to Prevent Anterior Segment Inflammation After Phacoemulsification and Intraocular Lens Implantation
Status:
COMPLETED
Status Verified Date:
2006-06
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:
None
Brief Summary:
The purpose of this study is to compare the effectiveness of Acular LS and Lotemax in the prevention of inflammation in the eye after cataract surgery Acular LS is made by Allergan Inc It is a nonsteroidal anti-inflammatory drug NSAID and is approved by the Food and Drug Administration FDA for use following cataract surgery Lotemax is made by Bausch Lomb It is a steroid and is also approved by the FDA for use following cataract surgery
Detailed Description:
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug NSAIDs which when administered systemically has demonstrated analgesic anti-inflammatory and anti-pyretic activity The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis cyclo-oxigenase inhibitors However they leave the lipoxygenase pathway free to generate leukotrienes This pharmacodynamic activity has been speculated as a reason why NSAIDs produce less ocular side effects than corticosteroids It has been widely used in ophthalmology In 1987 Flach1 published its effectiveness in the treatment of aphakic and pseudophakic macular edema Its efficacy after cataract surgery has been shown2 and it has been compared to topical steroids after extra-capsular cataract extraction345 and phacoemulsification67 It has been used as analgesic after radial keratotomyRK89 photorefractive keratectomy PRK10 and laser in situ keratomileusis LASIK11
The purpose of this study is to compare the effectiveness of the NSAID ketorolac tromethamine ophthalmic solution 04 with the steroid loteprednol etabonate ophthalmic suspension 05 for preventing anterior segment inflammation after routine cataract surgery
The purpose of this study is to compare the effectiveness of the NSAID ketorolac tromethamine ophthalmic solution 04 with the steroid loteprednol etabonate ophthalmic suspension 05 for preventing anterior segment inflammation after routine cataract surgery
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