Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02978183
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2016-11-28
Brief Title:
Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis
Sponsor:
Noveome Biotherapeutics formerly Stemnion
Organization:
Noveome Biotherapeutics formerly Stemnion
Study Overview
Official Title:
A Multi-Center Double-Masked Randomized Phase 2 Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model
Status:
COMPLETED
Status Verified Date:
2023-03
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 efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis
Detailed Description:
The study is a multi-center double-masked randomized placebo-controlled modified conjunctival allergen challenge CAC model The primary endpoints of ocular itching and conjunctival redness will be evaluated at the subjects final visit Subjects who meet inclusion criteria will be randomized to one of two treatment groups 11 Randomization will be stratified by average post-CAC itching scores at baseline
Subjects will be evaluated at baseline and on Days 6 7 and 8
Subjects will be evaluated at baseline and on Days 6 7 and 8
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