Ignite Creation Date:
2024-05-06 @ 1:07 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01730872
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2012-11-15
Brief Title:
Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
Sponsor:
ORA Inc
Organization:
ORA Inc
Study Overview
Official Title:
A Single-Center Double-Masked Randomized Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution 1 Compared to Placebo in a Modified Conjunctival Allergen Challenge CAC Model
Status:
COMPLETED
Status Verified Date:
2019-06
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 evaluate the effectiveness of the modified Conjunctival Allergen Challenge CAC and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication
Prednisolone assessed by the following measures
Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness
Prednisolone assessed by the following measures
Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness
Detailed Description:
Prospective single center randomized double-masked placebo controlled study Subjects will be randomized to one of the following treatment arms to dose four times per day QID for 4 days between Visits 3 and 4
Prednisolone phosphate Tears Naturale II Ophthalmic Solution Placebo
Duration
Approximately 2 weeks
Controls
Artificial Tears Tears Naturale II
Prednisolone phosphate Tears Naturale II Ophthalmic Solution Placebo
Duration
Approximately 2 weeks
Controls
Artificial Tears Tears Naturale II
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