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COMPLETED
NCT07869953
PHASE1/PHASE2

Oftac Eye Drops (0.05% Tacrolimus Ophthalmic Emulsion) for the Treatment of Active Non-infectious Anterior Uveitis

Sponsor: BioNanoSim Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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