Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-03-02 @ 4:26 AM
Study NCT ID:
NCT05283395
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2022-03-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rocklatan® Evaluation
Sponsor:
Aerie Pharmaceuticals
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label Rocklatan® (Netarsudil/Latanoprost Ophthalmic Solution) 0.02%/0.005% Evaluation of IOP Lowering Efficacy and Safety as Replacement of Current Medical Therapy Regimen for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension
Status:
COMPLETED
Status Verified Date:
2024-01
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 objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).
Detailed Description:
Enrollment will be stratified according to subject's IOP-lowering medical therapy regimen as follows:
* Latanoprost monotherapy (Latanoprost Mono)
* Latanoprost plus 1 additional IOP-lowering agent (Latanoprost +1)
* Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2)
Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.
* Latanoprost monotherapy (Latanoprost Mono)
* Latanoprost plus 1 additional IOP-lowering agent (Latanoprost +1)
* Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2)
Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: