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Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w/ Elevated Eye Pressure

NCT06144918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-14

Study results available
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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.

Conditions

Interventions

DRUG

SBI-100 Ophthalmic Emulsion, 0.5%

0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop

DRUG

SBI-100 Ophthalmic Emulsion, 1.0%

1.0% (10 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop

DRUG

SBI-100 Ophthalmic Emulsion, Placebo

Placebo, SBI-100 Ophthalmic Emulsion eyedrop without the active ingredient (SBI-100)

Sponsors & Collaborators

  • Skye Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Tu Diep · Skye Bioscience, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-09
Primary Completion
2024-02-22
Completion
2024-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06144918 on ClinicalTrials.gov