Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 1:49 PM
Study NCT ID:
NCT01534195
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2012-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Sponsor:
ORA, Inc.
Organization:
Study Overview
Official Title:
A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model
Status:
COMPLETED
Status Verified Date:
2012-07
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:
* Ocular itching
* Conjunctival redness
Prednisolone, assessed by the following measures:
* 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 8 days between Visits 4 and 5.
* Prednisolone phosphate
* Tears Naturale II Ophthalmic Solution (Placebo)
Duration:
Approximately 19 days
Controls:
Artificial Tears (Tears Naturale® II)
* Prednisolone phosphate
* Tears Naturale II Ophthalmic Solution (Placebo)
Duration:
Approximately 19 days
Controls:
Artificial Tears (Tears Naturale® II)
Study Oversight
Has Oversight DMC:
False
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?: