Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01479374
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2011-11-22
Brief Title:
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge CAC Model
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
A Multi-Center Randomized Double-Masked Vehicle and Active Controlled Parallel-Group Efficacy and Safety Study of AL-4943A Ophthalmic Solution 077 in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge CAC Model
Status:
COMPLETED
Status Verified Date:
2013-05
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 was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge CAC model
Detailed Description:
This study consisted of 5 Visits Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge CAC model which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process Patients demonstrating a positive reaction to the CAC at Visit 1 screening and Visit 2 confirmatory were randomized to treatment at Visit 3 Day 0 The test article was instilled at Visit 3 with treatment efficacy CAC performed at 24 hours duration of action The test article was instilled again at Visit 4 Day 14 with treatment efficacy CAC performed at 16 hours duration of action The test article was instilled a final time at Visit 5 Day 21 with treatment efficacy performed at onset of action
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