Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144918
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-11-14
Brief Title:
Phase 2 Placebo-Controlled Study Assessing the Safety and Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Patients With Elevated Eye Pressure
Sponsor:
Skye Bioscience Inc
Organization:
Skye Bioscience Inc
Study Overview
Official Title:
A Phase 2 Double-Masked Randomized Placebo-Controlled Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of Two Concentrations of SBI-100 Ophthalmic Emulsion in Patients With Elevated Intraocular Pressure
Status:
COMPLETED
Status Verified Date:
2023-11
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 goal of this clinical trial is to test in patients with glaucoma and elevated pressure in the eye The main questions it aims to answer are ability to lower pressure in the eye safety in the eye and the body of patients with elevated pressure in the eye Patients will be randomly given either
05 5 mgmL SBI-100 Ophthalmic Emulsion
10 10 mgmL SBI-100 Ophthalmic Emulsion
Placebo Ophthalmic Emulsion
Patients will be tested before starting and will have one drop of the product placed into each eye twice a day for 14 days by the site and by the patient At the end of the study researchers will compare the groups to see if there is a change from before use of SBI-100 Ophthalmic Emulsion to the end of study
05 5 mgmL SBI-100 Ophthalmic Emulsion
10 10 mgmL SBI-100 Ophthalmic Emulsion
Placebo Ophthalmic Emulsion
Patients will be tested before starting and will have one drop of the product placed into each eye twice a day for 14 days by the site and by the patient At the end of the study researchers will compare the groups to see if there is a change from before use of SBI-100 Ophthalmic Emulsion to the end of study
Detailed Description:
None
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