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NCT06144918 · ClinicalTrials.gov registry record · Phase 2
Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w/ Elevated Eye Pressure
A Phase 2 study, sponsored by Skye Bioscience.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT06144918: Completed Phase 2 study, sponsored by Skye Bioscience.
NCT06144918 is a Phase 2 study that has completed, run by Skye Bioscience. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06144918, a Phase 2 study, has completed, sponsored by Skye Bioscience.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
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)).
Interventions
- DRUG SBI-100 Ophthalmic Emulsion, 0.5%
- DRUG SBI-100 Ophthalmic Emulsion, 1.0%
- DRUG SBI-100 Ophthalmic Emulsion, Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2023-11-09 |
| Est. Completion | 2024-02-22 |
| Phase | Phase 2 |
What the finished NCT06144918 record still lists
NCT06144918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which SBI-100 Ophthalmic Emulsion, 0.5% is the first listed.
NCT06144918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06144918 about?
NCT06144918 is a clinical study titled "Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w/ Elevated Eye 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 eith...
What is the current status of trial NCT06144918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2023-11-09. Estimated completion is 2024-02-22.
What interventions are being tested in trial NCT06144918?
The interventions under investigation include: SBI-100 Ophthalmic Emulsion, 0.5% (DRUG), SBI-100 Ophthalmic Emulsion, 1.0% (DRUG), SBI-100 Ophthalmic Emulsion, Placebo (DRUG).
Who is sponsoring clinical trial NCT06144918?
This trial is sponsored by Skye Bioscience, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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