Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w⦠(NCT06144918) | Clinical Trial Compass
CompletedPhase 2
Ph2 Placebo-Controlled Study for Safety & Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Pts w/ Elevated Eye Pressure
United States56 participantsStarted 2023-11-09
Plain-language 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: β’ ability to lower pressure in the eye β’ 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. At least 18 years of age or greater at time of informed consent.
β. Diagnosis of either primary open angle glaucoma (POAG) or ocular hypertension (OHT) in each eye.
β. Intraocular Pressure (IOP) Criteria:
β. 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.
β. If treatment naΓ―ve, Screening IOP is β₯ 21 and β€ 36 mmHg in each eye, and in the opinion of the Investigator, is likely to be controlled on a single IOP-lowering therapy.
β. 08:00 Hour IOP is between 21 and 36 mmHg in each eye on Day-1 and Day 1.
β. Central corneal thickness between 480 and 620 ΞΌm at Screening in each eye.
β. Best correct visual acuity (BCVA) for distance equivalent to 20/100 or better in each eye at Screening and Day 1 (pre-dose).
Exclusion criteria
β
What they're measuring
1
Change From Baseline in Ocular Hypertension as Measured by Intraocular Pressure (IOP)
Timeframe: baseline and day 14
2
Ocular and Systemic Safety as Assessed by Treatment Emergent Adverse Events (TEAEs)
. Mean/Median intraocular pressure \> 36 mmHg at Screening and/or any time prior to treatment administration.
β. 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.
β. Has planned ocular surgeries/procedures within the duration of the study.
β. Any occurrences of the following prior to Day 1:
β. Ocular trauma or surgery within 6 months
β. Ocular laser treatments within 3 months
β. In the opinion of the Investigator history or evidence of clinically significant ocular inflammation, including but not limited to blepharitis, conjunctivitis, etc.
β. History of recurrent ocular herpes (simplex or zoster)