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.
This is a multi-center, randomized, double-masked, placebo-controlled Phase 2 study to evaluate the ocular hypotensive efficacy, safety, and tolerability of SBI-100 Ophthalmic Emulsion after 14 days of binocular dosing, twice daily (BID). There will be a 35-day screening period, including wash-out (if needed), followed by a visit on Day-1 to confirm eligibility. The first dose will be administered by the staff immediately after the (eligibility) 08:00 IOP measurement on Day 1, with subsequent study assessments up to 8 hours post-dose. The PM (evening) dose will be self-administered by the patient at home, approximately 12 hours after the AM (morning) dose. The patient will self-administer study treatment on Days 2 through 6 in the AM and PM. On Day 7, the patient will return to have the AM dose administered by site staff immediately after the 08:00 IOP measurement has been taken. Subsequent assessments will be performed in a similar fashion as Day 1 with study assessments up to 8 hours post-dose. Patient will self-administer the Day 7 PM dose and the AM and PM doses on Days 8 through 13. On Day 14, the patient will return to have the AM dose administered by site and assessments similar to that of Days 1 and 7, the patient may complete the final dose on Day 14 at the site approximately 12 hours after the AM dose and have end of study (EOS) procedures performed. Or the patient may choose to self-administer the Day 14 PM dose at home and return to the site within 2 days for EOS visit.IOP efficacy will be evaluated by Goldmann applanation tonometry. Safety/tolerability will be evaluated by review of ocular signs and symptoms through Best Corrected Visual Acuity (BCVA), ophthalmic assessments, ocular comfort patient-reported outcome (PRO), vital signs, and other standard safety measures Diagnosis and main criteria for inclusion: Patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) Screening: up to 35 days, including wash-out from any topical pharmacological IOP-lowering therapies (if required) Treatment: 2 weeks (14 days) Follow up: Up to 2 days after the last dose on Day 14
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
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)
Global Research Management, Inc.
Glendale, California, United States
Eye Research Foundation
Newport Beach, California, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP)
To evaluate the diurnal ocular hypotensive efficacy of 2 dose levels of SBI-100 Ophthalmic Emulsion compared to placebo in patients with elevated Intraocular Pressure (IOP). IOP was measured by Goldmann applanation tonometry and values were compared between baseline and Day 14 (evaluation of mean change in mmHg (millimeters of mercury)).
Time frame: baseline and day 14
Ocular and Systemic Safety as Assessed by Treatment Emergent Adverse Events (TEAEs)
To evaluate the ocular and systemic safety of SBI-100 Ophthalmic Emulsion in patients with elevated IOP. Safety and tolerability were evaluated by review of ocular signs and symptoms through use of BCVA (best corrected visual acuity; change in score from baseline to Day 14), ophthalmic assessments) including slit lamp biomicroscopy, dilated fundus exam, pupil diameter, visual field and pachymetry), ocular comfort patient reported outcome, vital signs, assessment of adverse events (ocular and non-ocular).
Time frame: baseline up to day 16
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