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Phase 2, Placebo-Controlled, Study Assessing the Safety and Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Patients With Elevated Eye Pressure

Ocular Hypertension Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06144918
Study type Interventional
Source Skye Bioscience, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 9, 2023
Completion date February 22, 2024
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