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

Prior treatment

• 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.
• 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:
  • 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
• Will require contact lenses and cannot refrain from using them at least 7 days prior to Day 1 and throughout the study.
  • General/Systemic:
• 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.

Other illness

• 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.
• 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.

Other

• Either eye:
• Has planned ocular surgeries/procedures within the duration of the study.
• Visual field loss, in the opinion of the Investigator, is functionally significant
• Participation in any investigational study within 30 days of screening.
• 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.

• 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).