Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863365
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-04-26
Brief Title:
A Study of Efficacy and Safety of PHP-201 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Sponsor:
pH Pharma
Organization:
pH Pharma
Study Overview
Official Title:
A Multi-center Randomized Placebo-controlled Double-blind Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PHP-201 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
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:
This is a phase 3 study to confirm the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension
Detailed Description:
As a selective ROCK inhibitor PHP-201 is designed to alleviate the side effects which are the disadvantages of existing intraocular pressure reducing agents while exhibiting sufficient intraocular pressure-lowering effect in glaucoma patients This clinical trial aims to provide a new therapeutic option by evaluating the efficacy and safety of PHP-201 05 in patients with primary open-angle glaucoma or ocular hypertension who require intraocular pressure reduction therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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