Status:
COMPLETED
Phase 2, Placebo-Controlled, Study Assessing the Safety and Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Patients With Elevated Eye Pressure
Lead Sponsor:
Skye Bioscience, Inc.
Conditions:
Primary Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06144918
Start Date
November 9 2023
End Date
February 22 2024
Last Update
March 15 2024
Active Locations (3)
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1
Global Research Management, Inc.
Glendale, California, United States, 91204
2
Eye Research Foundation
Newport Beach, California, United States, 92663
3
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States, 16066