NCT06144918Phase 2Completed

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

Study sponsor: Skye Bioscience, Inc. · SKYE

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-02-22Actual

Enrollment · participants56Actual

Source updated2026-01-14Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Primary Open Angle Glaucoma; Ocular Hypertension

Treatments or interventions studied

SBI-100 Ophthalmic Emulsion, 0.5%Drug
SBI-100 Ophthalmic Emulsion, 1.0%Drug
SBI-100 Ophthalmic Emulsion, PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP); description: 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)).; timeFrame: baseline and day 14; measure: Ocular and Systemic Safety as Assessed by Treatment Emergent Adverse Events (TEAEs); description: 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).; timeFrame: baseline up to day 16

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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