Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02482129
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2015-06-23
Brief Title:
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
A Multicenter Randomized Double-Masked Active-Controlled Study to Evaluate the Safety and Efficacy of LME636 in Patients With Acute Anterior Uveitis
Status:
COMPLETED
Status Verified Date:
2017-07
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 the study is to determine whether topical ocular administration of LME636 60 mgmL is efficacious in resolving the ocular inflammation in the anterior chamber AC associated with acute anterior uveitis AAU
Detailed Description:
Eligible subjects will be randomized to LME636 or Dexamethasone in a 31 ratio at the time they present to the trial site with the AAU flare and will enter treatment for 28 full days Subjects with worsening disease from Visit 2Day 4 onward or subjects without improvement after 14 days of treatment will be discontinued from treatment unmasked and treated with a rescue regimen at the discretion of the investigator
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