Primary Open Angle GlaucomaPhase 2NCT06144918
Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w/ Elevated Eye Pressure
A Phase 2 study testing SBI-100 Ophthalmic Emulsion, 0.5% and SBI-100 Ophthalmic Emulsion, 1.0% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Skye Bioscience, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- SBI-100 Ophthalmic Emulsion, 0.5% and SBI-100 Ophthalmic Emulsion, 1.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Nov 2023to 22 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 20Show fewer
- 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
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Global Research Management, Inc.
Glendale, California, 91204
Eye Research Foundation
Newport Beach, California, 92663
About this study
Official title: A Phase 2, Double-Masked, Randomized, Placebo-Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of Two Concentrations of SBI-100 Ophthalmic Emulsion in Patients With Elevated Intraocular Pressure
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.
Read the detailed description
This is a multi-center, randomized, double-masked, placebo-controlled Phase 2 study to evaluate the ocular hypotensive efficacy, safety, and tolerability of SBI-100 Ophthalmic Emulsion after 14 days of binocular dosing, twice daily (BID).
There will be a 35-day screening period, including wash-out (if needed), followed by a visit on Day-1 to confirm eligibility. The first dose will be administered by the staff immediately after the (eligibility) 08:00 IOP measurement on Day 1, with subsequent study assessments up to 8 hours post-dose. The PM (evening) dose will be self-administered by the patient at home, approximately 12 hours after the AM (morning) dose. The patient will self-administer study treatment on Days 2 through 6 in the AM and PM. On Day 7, the patient will return to have the AM dose administered by site staff immediately after the 08:00 IOP measurement has been taken. Subsequent assessments will be performed in a similar fashion as Day 1 with study assessments up to 8 hours post-dose. Patient will self-administer the Day 7 PM dose and the AM and PM doses on Days 8 through 13. On Day 14, the patient will return to have the AM dose administered by site and assessments similar to that of Days 1 and 7, the patient may complete the final dose on Day 14 at the site approximately 12 hours after the AM dose and have end of study (EOS) procedures performed. Or the patient may choose to self-administer the Day 14 PM dose at home and return to the site within 2 days for EOS visit.IOP efficacy will be evaluated by Goldmann applanation tonometry. Safety/tolerability will be evaluated by review of ocular signs and symptoms through Best Corrected Visual Acuity (BCVA), ophthalmic assessments, ocular comfort patient-reported outcome (PRO), vital signs, and other standard safety measures
Diagnosis and main criteria for inclusion: Patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
Screening: up to 35 days, including wash-out from any topical pharmacological IOP-lowering therapies (if required) Treatment: 2 weeks (14 days) Follow up: Up to 2 days after the last dose on Day 14
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- SBI-100 Ophthalmic Emulsion, 0.5%, SBI-100 Ophthalmic Emulsion, 1.0%, SBI-100 Ophthalmic Emulsion, Placebo
- Keywords
- glaucoma, IOP, ocular hypertension, POAG
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBI-100 Ophthalmic Emulsion, 0.5%Drug
0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop
SBI-100 Ophthalmic Emulsion, 1.0%Drug
1.0% (10 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop
SBI-100 Ophthalmic Emulsion, PlaceboDrug
Placebo, SBI-100 Ophthalmic Emulsion eyedrop without the active ingredient (SBI-100)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: SBI-100 Ophthalmic Emulsion, 1.0% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 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).
Measured: baseline up to day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start9 Nov 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skye Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tu Diep, Study chair, Skye Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144918
- Sponsor's protocol ID
- SBI-100-201
- Status last verified
- May 2025
- First submitted
- 14 Nov 2023
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Masked, Randomized, Placebo-Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of Two Concentrations of SBI-100 Ophthalmic Emulsion in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT06144918
- Acronym / sponsor ID
- SBI-100-201
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, IOP, ocular hypertension, POAG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Skye Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, randomized, double-masked, placebo-controlled Phase 2 study to evaluate the ocular hypotensive efficacy, safety, and tolerability of SBI-100 Ophthalmic Emulsion after 14 days of binocular dosing, twice daily (BID).
There will be a 35-day screening period, including wash-out (if needed), followed by a visit on Day-1 to confirm eligibility. The first dose will be administered by the staff immediately after the (eligibility) 08:00 IOP measurement on Day 1, with subsequent study assessments up to 8 hours post-dose. The PM (evening) dose will be self-administered by the patient at home, approximately 12 hours after the AM (morning) dose. The patient will self-administer study treatment on Days 2 through 6 in the AM and PM. On Day 7, the patient will return to have the AM dose administered by site staff immediately after the 08:00 IOP measurement has been taken. Subsequent assessments will be performed in a similar fashion as Day 1 with study assessments up to 8 hours post-dose. Patient will self-administer the Day 7 PM dose and the AM and PM doses on Days 8 through 13. On Day 14, the patient will return to have the AM dose administered by site and assessments similar to that of Days 1 and 7, the patient may complete the final dose on Day 14 at the site approximately 12 hours after the AM dose and have end of study (EOS) procedures performed. Or the patient may choose to self-administer the Day 14 PM dose at home and return to the site within 2 days for EOS visit.IOP efficacy will be evaluated by Goldmann applanation tonometry. Safety/tolerability will be evaluated by review of ocular signs and symptoms through Best Corrected Visual Acuity (BCVA), ophthalmic assessments, ocular comfort patient-reported outcome (PRO), vital signs, and other standard safety measures
Diagnosis and main criteria for inclusion: Patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)
Screening: up to 35 days, including wash-out from any topical pharmacological IOP-lowering therapies (if required) Treatment: 2 weeks (14 days) Follow up: Up to 2 days after the last dose on Day 14
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SBI-100 Ophthalmic Emulsion, 0.5% | Experimental | Drug: 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 Placebo | Placebo comparator | Drug: SBI-100 Ophthalmic Emulsion, PlaceboAll 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% | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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).
Key exclusion criteria (20 listed)
- 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:
- Visual field loss, in the opinion of the Investigator, is functionally significant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBI-100 Ophthalmic Emulsion, 0.5%0.5% (5 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop | Drug | SBI-100 Ophthalmic Emulsion, 0.5% |
| SBI-100 Ophthalmic Emulsion, 1.0%1.0% (10 mg/mL) SBI-100 Ophthalmic Emulsion eyedrop | Drug | SBI-100 Ophthalmic Emulsion, 1% |
| SBI-100 Ophthalmic Emulsion, PlaceboPlacebo, SBI-100 Ophthalmic Emulsion eyedrop without the active ingredient (SBI-100) | Drug | SBI-100 Ophthalmic Emulsion Placebo |
Primary outcome
Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP)
Time frame: 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)).
Ocular and Systemic Safety as Assessed by Treatment Emergent Adverse Events (TEAEs)
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tu Diep study chair
Skye Bioscience, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBI-100 Ophthalmic Emulsion, 0.5% and SBI-100 Ophthalmic Emulsion, 1.0% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Skye Bioscience, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP) (time frame: baseline and day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.