NCT06144918

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

Completed Phase 2 Results posted Last updated 14 January 2026

What this trial tests

Phase 2 trial testing SBI-100 Ophthalmic Emulsion, 0.5% in Primary Open Angle Glaucoma in 56 participants. Completed in 22 February 2024.

Timeline

9 November 2023

Primary endpoint
22 February 2024

22 February 2024

Quick facts

Lead sponsor	Skye Bioscience, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	56
Start date	9 November 2023
Primary completion	22 February 2024
Estimated completion	22 February 2024
Sites	3 locations across United States

Drugs / interventions tested

• SBI-100 Ophthalmic Emulsion, 0.5% — full drug profile →
• SBI-100 Ophthalmic Emulsion, 1.0% — full drug profile →
• SBI-100 Ophthalmic Emulsion, Placebo — full drug profile →

Conditions studied

• Primary Open Angle Glaucoma — all drugs for Primary Open Angle Glaucoma →
• Ocular Hypertension — all drugs for Ocular Hypertension →

Sponsor

Skye Bioscience, Inc. — full company profile →

Who can join

18 and older, any sex, with Primary Open Angle Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP) Primary · baseline and day 14

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)).

Group	Value	95% CI
SBI-100 Ophthalmic Emulsion, 0.5%	-1.985	± 0.5039
SBI-100 Ophthalmic Emulsion 1.0%	-1.118	± 0.5041
Placebo	-0.827	± 0.5177

Ocular and Systemic Safety as Assessed by Treatment Emergent Adverse Events (TEAEs) Primary · baseline up to day 16

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).

Group	Value	95% CI
SBI-100 Ophthalmic Emulsion Placebo	3
SBI-100 Ophthalmic Emulsion, 0.5%	0
SBI-100 Ophthalmic Emulsion 1.0%	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline through end of study (approximately 16 days post first dose).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SBI-100 Ophthalmic Emulsion, 0.5%

Serious: 0/19 (0%)

Deaths: 0/19

SBI-100 Ophthalmic Emulsion, 1.0%

Serious: 0/19 (0%)

Deaths: 0/19

Placebo

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (17 terms — click to expand)

Reaction	System	SBI-100 Ophthalmic Emulsio…	SBI-100 Ophthalmic Emulsio…	Placebo
Instillation site irritation / burning less than one minute	General disorders	—	—	—
Instillation site irritation / stinging up on administration	General disorders	—	—	—
Instillation site irritation / stinging for 20 seconds	General disorders	—	—	—
Instillation site irritation / burning upon administration	General disorders	—	—	—
Bruised right hip secondary to fall	Musculoskeletal and connective tissue disorders	—	—	—
Conjunctival hyperemia	Eye disorders	—	—	—
Dry eye worsening	Eye disorders	—	—	—
Infections / nasopharyngitis / common cold	Infections and infestations	—	—	—
Instillation site erythema / redness less than 1 minute	General disorders	—	—	—
Instillation site irritation / burning for 15 minutes	General disorders	—	—	—
Instillation site irritation / burning up to 15 seconds	General disorders	—	—	—
Instillation site irritation / burning up to 5 minutes	General disorders	—	—	—
Minor concussion secondary to fall	Injury, poisoning and procedural complications	—	—	—
Ocular irritation	Eye disorders	—	—	—
Squamous cell carcinoma right side face	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Subconjunctival hemorrhage	Eye disorders	—	—	—
Vivid dreams	Psychiatric disorders	—	—	—

Data from ClinicalTrials.gov NCT06144918 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emulsion and Emulgel-Based Ophthalmic Drug Delivery Systems.
   Mohapatra D, Yang E, Corson TW. · · 2025 · cited 1× · PMID 41471020 · DOI 10.3390/pharmaceutics17121504