At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SBI-100 Ophthalmic Emulsion, 0.5%, SBI-100 Ophthalmic Emulsion, 1.0%, and 1 other intervention for Primary Open Angle Glaucoma and Ocular Hypertension. Completed, enrolled 56 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop
1.0% (10 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop
Placebo, SBI-100 Ophthalmic Emulsion eyedrop without the active ingredient (SBI-100)