A Phase 1/2 interventional study of Oftac: 0.05% tacrolimus ophthalmic emulsion in Non-Infectious Anterior Uveitis, sponsored by BioNanoSim Ltd.. Completed at 7 sites in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by BioNanoSim Ltd. · Phase 1/2, Interventional, and Treatment
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:
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.
This is a multicenter, open label Phase 1/2a study designed to assess safety and tolerability of Oftac eye drops in active non-infectious anterior uveitis patients, as well as to evaluate preliminary indications of efficacy. Patients will be treated with the Investigational treatment, Oftac 0.05% tacrolimus ophthalmic emulsion, administered 4 times a day (QID) as a single drop to the affected eye. Dose administrations should be at approximately the same time every day during the entire study period.
345 studies on the registry are indexed under Uveitis; 38 are open to participants now.
This study's enrollment of 18 is below the median of 30 across 214 interventional studies indexed under Uveitis.
Browse Uveitis studies →This is the only study on the registry with BioNanoSim Ltd. as lead sponsor.
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Patient has one of the following:
4.1 A history of unilateral or bilateral ongoing (>/= 2 months) non-infectious anterior uveitis with chronic cellular infiltrate of +1 to +2 cells that has responded to steroids 4.2 A well-defined history of at least one episodes of acute anterior uveitis that responded to topical steroids and is currently with +1 to +2 cells, including patients that are on systemic stable therapy (oral immunosuppressive or injectable anti-TNF alpha inhibitors)
Exclusion Criteria:
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.
Adverse events
Time frame: 6 weeks
Change in Best Corrected Visual Acuity (BCVA)
Time frame: 6 weeks
Change in Intraocular Pressure (IOP)
Time frame: 6 weeks
Maximal plasma tacrolimus concentrations (Cmax)
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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