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Oftac Eye Drops (0.05% Tacrolimus Ophthalmic Emulsion) for the Treatment of Active Non-infectious Anterior Uveitis
Sponsor: BioNanoSim Ltd.
Summary
The goal of this clinical trial is to assess the safety and tolerability of Oftac in active non-infectious anterior uveitis patients. The main questions it aims to answer are: 1. Are adverse events observed during the treatment period and if so, what are their severity? 2. What is the change in Best Corrected Visual Acuity (BCVA) test using the Early Treatment Diabetic Retinopathy Study (ETDRS) acuity chart from baseline to Day 29? 3. What is the change in Intraocular Pressure (IOP) from baseline to Day 29? The expected study duration for each patient will be up to 6 weeks including up to 1 week for screening, a 4-week treatment period and a 1-week safety follow-up period. Patients will be administered Oftac 0.05% eye drops four (4) times every day, for up to six weeks.
Official title: A Multicenter, Open Label Phase-1/2a Study of Oftac Eye Drops in Active Non-Infectious Anterior Uveitis Patients
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2024-03-07
Completion Date
2025-03-25
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Oftac: 0.05% tacrolimus ophthalmic emulsion
Oftac 0.05% eye drops administered as a single drop four (4) times every day (QID) as a monotherapy in patients not currently being administered another treatment, or as an add-on therapy to an existing therapeutic regimen.
Locations (7)
Department of Ophthalmology, Soroka University Medical Center, Ben-Gurion University of the Negev
Beersheba, Israel
Department of Ophthalmology, Bnai Zion Medical Center
Haifa, Israel
Department of Ophthalmology, Carmel Medical Center, The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology
Haifa, Israel
Department of Ophthalmology, Rambam Medical Center, The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology
Haifa, Israel
Department of Ophthalmology, Hadassah Medical Organization and Faculty of Medicine, Hebrew University of Jerusalem
Jerusalem, Israel
Department of Ophthalmology, Rabin Medical Center
Petah Tikva, Israel
Shamir Medical Center
Ẕerifin, Israel