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

NCT06144918 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SBI-100-201
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

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 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

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

glaucoma; IOP; ocular hypertension; POAG

Outcome Measures

Primary Outcomes (2)

• 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)).

  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).

  baseline up to day 16

Study Arms (3)

SBI-100 Ophthalmic Emulsion, 0.5%

EXPERIMENTAL

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%

SBI-100 Ophthalmic Emulsion Placebo

PLACEBO COMPARATOR

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

SBI-100 Ophthalmic Emulsion, 1%

EXPERIMENTAL

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%

Interventions

SBI-100 Ophthalmic Emulsion, 0.5% DRUG

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

SBI-100 Ophthalmic Emulsion, 0.5%

SBI-100 Ophthalmic Emulsion, 1.0% DRUG

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

SBI-100 Ophthalmic Emulsion, 1%

SBI-100 Ophthalmic Emulsion, Placebo DRUG

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

SBI-100 Ophthalmic Emulsion Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• :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).

You may not qualify if:

• 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:

Sponsors & Collaborators

• Skye Bioscience, Inc.: lead

Study Sites (3)

Global Research Management, Inc.

Glendale, California, 91204, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Skye Bioscience

info@skyebioscience.com

858-410-0266

Study Officials

• Tu Diep

  Skye Bioscience, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 22, 2023
• Study Start: November 9, 2023
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)