Trial Outcomes & Findings for Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w/ Elevated Eye Pressure (NCT NCT06144918)

Last Updated: 2026-01-14

Results Overview

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)).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

baseline and day 14

Results posted on

2026-01-14

Participant Flow

There was a screening/washout period of up to 35 days to washout procedures and medications prohibited by the study protocol. At Visit 3 (Day 1), eligible patients were randomized 1:1:1 to IP in a double-masked fashion (SBI-100 0.5%, SBI-100 1.0% or placebo). Eleven (11) participants were screen failures and therefore, did not receive a treatment assigned. A total of 56 participants were screened and enrolled.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	SBI-100 Ophthalmic Emulsion, 0.5% 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 SBI-100 ophthalmic emulsion, 0.5%: 0.5% (5 mg/ml) SBI-100 ophthalmic emulsion	SBI-100 Ophthalmic Emulsion 1.0% 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 SBI-100 ophthalmic emulsion, 1.0%: 1.0% (10 mg/ml) SBI-100 ophthalmic emulsion	Placebo 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 Placebo
Overall Study STARTED	19 19	19 19	18 18
Overall Study COMPLETED	19 19	19 19	18 18
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBI-100 Ophthalmic Emulsion, 0.5% n=19 Participants 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 SBI-100 ophthalmic emulsion, 0.5%: 0.5% (5 mg/ml) SBI-100 ophthalmic emulsion	SBI-100 Ophthalmic Emulsion 1.0% n=19 Participants 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 SBI-100 ophthalmic emulsion, 1.0%: 1.0% (10 mg/ml) SBI-100 ophthalmic emulsion	Placebo n=18 Participants 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 Placebo	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=9 Participants	3 Participants n=6 Participants	4 Participants n=9 Participants	14 Participants n=205 Participants
Age, Categorical >=65 years	12 Participants n=9 Participants	16 Participants n=6 Participants	14 Participants n=9 Participants	42 Participants n=205 Participants
Sex: Female, Male Female	10 Participants n=9 Participants	7 Participants n=6 Participants	11 Participants n=9 Participants	28 Participants n=205 Participants
Sex: Female, Male Male	9 Participants n=9 Participants	12 Participants n=6 Participants	7 Participants n=9 Participants	28 Participants n=205 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=9 Participants	7 Participants n=6 Participants	5 Participants n=9 Participants	16 Participants n=205 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=9 Participants	12 Participants n=6 Participants	13 Participants n=9 Participants	40 Participants n=205 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Race (NIH/OMB) Asian	2 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	2 Participants n=205 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	2 Participants n=6 Participants	0 Participants n=9 Participants	2 Participants n=205 Participants
Race (NIH/OMB) White	17 Participants n=9 Participants	17 Participants n=6 Participants	18 Participants n=9 Participants	52 Participants n=205 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants	0 Participants n=205 Participants
Region of Enrollment United States	19 participants n=9 Participants	19 participants n=6 Participants	18 participants n=9 Participants	56 participants n=205 Participants
Diagnosis for Study Inclusion OHT (ocular hypertension)	9 Participants n=9 Participants	4 Participants n=6 Participants	9 Participants n=9 Participants	22 Participants n=205 Participants
Diagnosis for Study Inclusion POAG (primary open angle glaucoma)	7 Participants n=9 Participants	15 Participants n=6 Participants	8 Participants n=9 Participants	30 Participants n=205 Participants
Diagnosis for Study Inclusion Both OHT and POAG	3 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants	4 Participants n=205 Participants
Study Eye OD (oculus dexter; right eye)	10 Participants n=9 Participants	11 Participants n=6 Participants	13 Participants n=9 Participants	34 Participants n=205 Participants
Study Eye OS (oculus sinister; left eye)	9 Participants n=9 Participants	8 Participants n=6 Participants	5 Participants n=9 Participants	22 Participants n=205 Participants

PRIMARY outcome

Timeframe: baseline and day 14

Outcome measures

Outcome measures
Measure	SBI-100 Ophthalmic Emulsion, 0.5% n=19 Participants 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 SBI-100 ophthalmic emulsion, 0.5%: 0.5% (5 mg/ml) SBI-100 ophthalmic emulsion	SBI-100 Ophthalmic Emulsion 1.0% n=19 Participants All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% of placebo, SBI-100 ophthalmic emulsion. SBI-100 ophthalmic emulsion, 1.0%. 1.0% (10 mg/ml) SBI-100 ophthalmic emulsion	Placebo n=18 Participants All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% of placebo, SBI-100 ophthalmic emulsion. Placebo
Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP)	-1.985 Change in IOP mmHg Standard Error 0.5039	-1.118 Change in IOP mmHg Standard Error 0.5041	-0.827 Change in IOP mmHg Standard Error 0.5177

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	SBI-100 Ophthalmic Emulsion, 0.5% n=18 Participants 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 SBI-100 ophthalmic emulsion, 0.5%: 0.5% (5 mg/ml) SBI-100 ophthalmic emulsion	SBI-100 Ophthalmic Emulsion 1.0% n=19 Participants All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% of placebo, SBI-100 ophthalmic emulsion. SBI-100 ophthalmic emulsion, 1.0%. 1.0% (10 mg/ml) SBI-100 ophthalmic emulsion	Placebo n=19 Participants All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% of placebo, SBI-100 ophthalmic emulsion. Placebo
Ocular and Systemic Safety as Assessed by Treatment Emergent Adverse Events (TEAEs)	3 Events	0 Events	0 Events

Adverse Events

SBI-100 Ophthalmic Emulsion, 0.5%

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

SBI-100 Ophthalmic Emulsion, 1.0%

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Skye Bioscience

Phone: 858-410-0266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	SBI-100 Ophthalmic Emulsion, 0.5% n=19 participants at risk 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 SBI-100 ophthalmic emulsion, 0.5%: 0.5% (5 mg/ml) SBI-100 ophthalmic emulsion	SBI-100 Ophthalmic Emulsion, 1.0% n=19 participants at risk 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 SBI-100 ophthalmic emulsion, 1.0%: 1.0% (10 mg/ml) SBI-100 ophthalmic emulsion	Placebo n=18 participants at risk 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
General disorders Instillation site irritation / burning less than one minute	15.8% 3/19 • Number of events 3 • From baseline through end of study (approximately 16 days post first dose).	31.6% 6/19 • Number of events 6 • From baseline through end of study (approximately 16 days post first dose).	11.1% 2/18 • Number of events 2 • From baseline through end of study (approximately 16 days post first dose).
Musculoskeletal and connective tissue disorders Bruised right hip secondary to fall	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
Eye disorders Conjunctival hyperemia	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
Eye disorders Dry eye worsening	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
Infections and infestations Infections / nasopharyngitis / common cold	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	5.6% 1/18 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).
General disorders Instillation site erythema / redness less than 1 minute	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
General disorders Instillation site irritation / burning upon administration	10.5% 2/19 • Number of events 2 • From baseline through end of study (approximately 16 days post first dose).	15.8% 3/19 • Number of events 3 • From baseline through end of study (approximately 16 days post first dose).	5.6% 1/18 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).
Psychiatric disorders Vivid dreams	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
General disorders Instillation site irritation / burning for 15 minutes	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
General disorders Instillation site irritation / burning up to 15 seconds	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	5.6% 1/18 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).
General disorders Instillation site irritation / burning up to 5 minutes	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
General disorders Instillation site irritation / stinging up on administration	21.1% 4/19 • Number of events 4 • From baseline through end of study (approximately 16 days post first dose).	26.3% 5/19 • Number of events 5 • From baseline through end of study (approximately 16 days post first dose).	5.6% 1/18 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).
General disorders Instillation site irritation / stinging for 20 seconds	21.1% 4/19 • Number of events 4 • From baseline through end of study (approximately 16 days post first dose).	26.3% 5/19 • Number of events 5 • From baseline through end of study (approximately 16 days post first dose).	5.6% 1/18 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).
Injury, poisoning and procedural complications Minor concussion secondary to fall	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
Eye disorders Ocular irritation	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma right side face	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	5.6% 1/18 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).
Eye disorders Subconjunctival hemorrhage	0.00% 0/19 • From baseline through end of study (approximately 16 days post first dose).	5.3% 1/19 • Number of events 1 • From baseline through end of study (approximately 16 days post first dose).	0.00% 0/18 • From baseline through end of study (approximately 16 days post first dose).