Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-31 @ 5:08 AM
Study NCT ID:
NCT03960866
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2019-05-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
Sponsor:
Ocuphire Pharma, Inc.
Organization:
Study Overview
Official Title:
Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
Status:
COMPLETED
Status Verified Date:
2023-08
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 objectives of this study are:
* To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT).
* To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle.
* To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.
* To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT).
* To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle.
* To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.
Detailed Description:
Placebo-controlled double-masked, multiple dose Phase 2 study in 40 patients with IOP ≥ 22 and ≤30 mmHg, evaluating ocular and systemic safety and efficacy following administration of Phentolamine mesylate 1.0% QD at 8PM to 10PM in both eyes for 14 days.
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?: