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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: SBI-100 Ophthalmic Emulsion, 0.5%
* Drug: SBI-100 Ophthalmic Emulsion, 1.0%
* Drug: SBI-100 Ophthalmic Emulsion, Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age or greater at time of informed consent. Diagnosis of either primary open angle glaucoma (POAG) or ocular hypertension (OHT) in each eye. Intraocular Pressure (IOP) Criteria: If currently on an IOP-lowering therapy, patient is willing to withhold therapy according to study requirements, and in the opinion of the Investigator, can do so without significant risk. If treatment naïve, Screening IOP is ≥ 21 and ≤ 36 mmHg in each eye, and in the opinion of the Investigator, is likely to be controlled on a single IOP-lowering therapy. 08:00 Hour IOP is between 21 and 36 mmHg in each eye on Day-1 and Day 1. Central corneal thickness between 480 and 620 μm at Screening in each eye. Best correct visual acuity (BCVA) for distance equivalent to 20/100 or better in each eye at Screening and Day 1 (pre-dose). Exclusion Criteria: Either eye: Mean/Median intraocular pressure > 36 mmHg at Screening and/or any time prior to treatment administration. Concurrent treatment for glaucoma requiring more than 2 topical therapies (either as 2 independent monotherapies or as fixed dose combination), oral IOP-lowering therapy and/or in the opinion of the Investigator cannot be controlled on a single IOP therapy. Has planned ocular surgeries/procedures within the duration of the study. Any occurrences of the following prior to Day 1: Ocular trauma or surgery within 6 months Ocular laser treatments within 3 months In the opinion of the Investigator history or evidence of clinically significant ocular inflammation, including but not limited to blepharitis, conjunctivitis, etc. History of recurrent ocular herpes (simplex or zoster) Previous glaucoma intraocular surgery or glaucoma laser procedure and/or refractive surgery (e.g., radial keratotomy, PRK, SLT, LASIK, etc.) within 6 months Ocular medication within 30 days prior, except for: i. IOP-lowering therapies (washed-out per study requirements) ii. Lid scrubs iii. Artificial tears, gels and/or ointments to treat dry eye disease that in the opinion of the Investigator is not considered chronic use Visual field loss, in the opinion of the Investigator, is functionally significant Will require contact lenses and cannot refrain from using them at least 7 days prior to Day 1 and throughout the study. General/Systemic: Participation in any investigational study within 30 days of screening. Known hypersensitivity or allergic reaction to cannabinoids, cannabis, sesame seed/oil or any component of the SBI-100 Ophthalmic Emulsion formulation and/or topical anesthetics. Females of childbearing potential (not confirmed as post-menopausal or surgically sterile within the 6 months prior to screening) who are pregnant, nursing, or planning a pregnancy during the study and not using a reliable method of contraception from screening until at least 30 days after the last dose. Males with partners of childbearing potential and do not agree to use a reliable method of contraception during the study and at least 30 days after the last dose. Patients with a history of substance or alcohol abuse, considered chronic tetrahydrocannabinol (THC) users and/or test positive for alcohol or illicit drug use at Screening or Day-1.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBI-100 Ophthalmic Emulsion, 0.5%<br>All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion | Drug: SBI-100 Ophthalmic Emulsion, 0.5%<br>* 0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop<br>|
| Placebo Comparator: SBI-100 Ophthalmic Emulsion Placebo<br>All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion | Drug: SBI-100 Ophthalmic Emulsion, Placebo<br>* Placebo, SBI-100 Ophthalmic Emulsion eyedrop without the active ingredient (SBI-100)<br>|
| Experimental: SBI-100 Ophthalmic Emulsion, 1%<br>All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion | Drug: SBI-100 Ophthalmic Emulsion, 1.0%<br>* 1.0% (10 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular hypotensive efficacy | 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) | baseline and day 14 | 
| Ocular and systemic safety | To evaluate the ocular and systemic safety of SBI-100 Ophthalmic Emulsion in patients with elevated IOP | baseline up to day 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular hypotensive efficacy at individual timepoints | To evaluate the ocular hypotensive efficacy at individual time points of SBI-100 Ophthalmic Emulsion in patients with elevated IOP | baseline through day 14 | 
| Application comfort | To evaluate the application comfort of SBI-100 Ophthalmic Emulsion | baseline up to day 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOP, glaucoma, ocular hypertension, POAG