Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410267
Status:
TERMINATED
Last Update Posted:
2016-08-09
First Post:
2006-12-11
Brief Title:
Trial Comparing Ketorolac Tromethamine 04 Prednisolone Acetate 1 in Reducing Post-SLT Anterior Chamber Flare Cells
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Randomized Prospective Double - Masked Controlled Trial Comparing Ketorolac Tromethamine 04 and Prednisolone Acetate 1 in Reducing Post-Selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Selective laser trabeculoplasty SLT is a new alternative to anti-glaucoma medications for the treatment of primary open angle glaucoma After SLT many patients experience mild to moderate inflammation inside the eye - specifically in the front chamber of the eye the part in front of the colored part of the eye This mild front chamber reaction is typically treated with anti-inflammatory agents such as corticosteroids and nonsteroidal anti-inflammatory agents NSAIDs Some physicians do not use these agents as they feel they may interfere with the way the laser works to treat glaucoma Topical applied to the surface corticosteroids can cause an increase in the pressure of the eye intraocular pressure or IOP cataract formation or a possible increase in infection with long-term use These side effects have not been reported to occur with NSAIDs which are effective in controlling pain after SLT and reducing signs of inflammation such as irritation swelling tenderness and soreness
This research study will compare an NSAID ketorolac tromethamine 04 Acular LS with a corticosteroid prednisolone acetate 1 Pred Forte and with a placebo which contains no active medicine Refresh Tears Ketorolac tromethamine 04 prednisolone acetate 1 and Refresh Tears are all FDA Food and Drug Administration approved for use in inflammation after surgery
This research study will compare an NSAID ketorolac tromethamine 04 Acular LS with a corticosteroid prednisolone acetate 1 Pred Forte and with a placebo which contains no active medicine Refresh Tears Ketorolac tromethamine 04 prednisolone acetate 1 and Refresh Tears are all FDA Food and Drug Administration approved for use in inflammation after surgery
Detailed Description:
Selective laser trabeculoplasty SLT is a new alternative to anti-glaucoma medications for the treatment of primary open angle glaucoma After SLT many patients experience mild to moderate inflammation inside the eye - specifically in the front chamber of the eye the part in front of the colored part of the eye This mild front chamber reaction is typically treated with anti-inflammatory agents such as corticosteroids and nonsteroidal anti-inflammatory agents NSAIDs Some physicians do not use these agents as they feel they may interfere with the way the laser works to treat glaucoma Topical applied to the surface corticosteroids can cause an increase in the pressure of the eye intraocular pressure or IOP cataract formation or a possible increase in infection with long-term use These side effects have not been reported to occur with NSAIDs which are effective in controlling pain after SLT and reducing signs of inflammation such as irritation swelling tenderness and soreness
This research study will compare an NSAID ketorolac tromethamine 04 Acular LS with a corticosteroid prednisolone acetate 1 Pred Forte and with a placebo which contains no active medicine Refresh Tears Ketorolac tromethamine 04 prednisolone acetate 1 and Refresh Tears are all FDA Food and Drug Administration approved for use in inflammation after surgery
To date there is no study that proves that any one of the three study medications is better than the others for care after SLT We plan to compare the effect of these anti-inflammatory drops in participants after selective laser trabeculoplasty to see if one works better at helping lower the pressure inside the eye after SLT or whether participants would do just as well with non-medicated eye drops We will also see how well these drops reduce any potential discomfort and swelling that arise
This research study will compare an NSAID ketorolac tromethamine 04 Acular LS with a corticosteroid prednisolone acetate 1 Pred Forte and with a placebo which contains no active medicine Refresh Tears Ketorolac tromethamine 04 prednisolone acetate 1 and Refresh Tears are all FDA Food and Drug Administration approved for use in inflammation after surgery
To date there is no study that proves that any one of the three study medications is better than the others for care after SLT We plan to compare the effect of these anti-inflammatory drops in participants after selective laser trabeculoplasty to see if one works better at helping lower the pressure inside the eye after SLT or whether participants would do just as well with non-medicated eye drops We will also see how well these drops reduce any potential discomfort and swelling that arise
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