Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441643
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Next Generation Rocklatan
Sponsor:
Alcon Research
Organization:
Alcon Research
Study Overview
Official Title:
A Phase II Prospective Two-Stage Double-Masked Randomized Multi-Center Controlled Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-17043 and PG043 AR-17043Latanoprost Ophthalmic Solutions in Subjects With Elevated Intraocular Pressure
Status:
RECRUITING
Status Verified Date:
2024-09
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 two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma OAG or ocular hypertension OHT
Detailed Description:
During Stage 1 approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms 3 different concentrations of AR-17043 placebo comparator or netarsudil 002 Rhopressa for a treatment duration of 7 days
During Stage 2 approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms low and high concentrations of PG043 AR-17043latanoprost 0005 AR-17043 high concentration latanoprost or netarsudil 002latanoprost 0005 Rocklatan for a treatment duration of 28 days
During Stage 2 approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms low and high concentrations of PG043 AR-17043latanoprost 0005 AR-17043 high concentration latanoprost or netarsudil 002latanoprost 0005 Rocklatan for a treatment duration of 28 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None