Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT06144918
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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:
* 0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion
* 1.0% (10 mg/mL) 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.
* 0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion
* 1.0% (10 mg/mL) 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:
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?:
None
Is an FDA AA801 Violation?: