Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 4:04 PM
Study NCT ID:
NCT04038034
Status:
UNKNOWN
Last Update Posted:
2020-04-28
First Post:
2019-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valuation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) in Patients Affected by Primary Open Angle Glaucoma
Sponsor:
VISUfarma SpA
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) 100 mg BID Oral Administration in Patients Affected by Primary Open Angle Glaucoma (POAG): a Randomized, Double Blind Study
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
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 randomized, double blind study with competitive enrolment, aimed to enroll a total of 70 patients with a diagnosis of primary open angle glaucoma (POAG).
Patients, after signing the Informed Consent, will enter into a 1- week screening phase during which the baseline tests will be conducted.
Subjects will be randomized in a 1:1 ratio to the following groups:
* group A of 35 patients treated with pressure lowering drugs and placebo;
* group B of 35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID.
Patients, after signing the Informed Consent, will enter into a 1- week screening phase during which the baseline tests will be conducted.
Subjects will be randomized in a 1:1 ratio to the following groups:
* group A of 35 patients treated with pressure lowering drugs and placebo;
* group B of 35 patients with pressure lowering drugs and COQUN oral formulation 100 mg BID.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: