Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w/ Elevated Eye Pressure
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.
Timeline
- Start
- 2023-11-09
- Primary completion
- 2024-02-22
- Completion
- 2024-02-22
Outcome
Missed primary endpoint
release “SBI-100 Ophthalmic Emulsion Phase 2a trial does not achieve target product profile; program discontinued” skyebioscience.com ↗
release “The study did not achieve a statistically significant improvement in IOP over placebo.” skyebioscience.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SBI-100 | Unknown | 0.5 % | Other |
| Subject | SBI-100 | Unknown | 1 % | Other |