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CompletedNCT07869953Updated Oct 13, 2026

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

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

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Mar 2024, registered Oct 2026).
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Non-Infectious Anterior Uveitis

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Keywords

  • Uveitis
  • Best Corrected Visual Acuity
  • Intraocular Pressure
  • Tacrolimus Ophthalmic emulsion
  • Topical Tacrolimus
03

In context

Uveitis

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 →

Lead sponsor

This is the only study on the registry with BioNanoSim Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able and willing to provide written informed consent
  2. Able and willing to follow all study instructions, restrictions and attend study visits
  3. Male and female patients 18 to 70 years of age
  4. 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)

  5. BCVA equal or better than 0.3 Log MAR in the non-investigated eye.

Exclusion criteria

Exclusion Criteria:

  1. Be a female of childbearing potential who is currently pregnant, nursing, or planning to become pregnant or nurse during the study
  2. Have known contraindications or a sensitivity to any of the study drugs or excipients
  3. Have an active ocular infection (bacterial, viral, or fungal)
  4. Have active non-uveitic ocular inflammation (e.g., severe blepharitis, any active allergic conjunctivitis, peripheral ulcerative keratitis or scleritis) in either eye
  5. Have a known history or diagnosis of ocular herpes-simplex infection
  6. Have active posterior-uveitis and/or active intermediate uveitis or any other form of active uveitis aside from anterior uveitis
  7. Have a history of old posterior uveitis, or scars or intermediate uveitis that was active during the last six months
  8. Have chronic Anterior Chamber (AC) flare >/= +3.
  9. Plan to have any form of eye surgery within the study period or less than 3 months prior to screening
  10. Have high myopia (above 9 diopters) or astigmatism (above 4 diopters) in the study eye
  11. Have IOP \< 6 millimeters of mercury (mmHg) or > 20 mmHg while being treated with more than two anti-glaucoma medications in the investigated eye on maximal antiglaucoma therapy
  12. Have clinically significant abnormal ophthalmic findings (e.g. central corneal scar, advanced guttata) or a known history of a clinically significant eye disease in either eye that may interfere with the study examinations and/or put the patient in any risk according to the Investigator's judgment.
  13. Patient is using a cytochrome P450-3A4 inhibitor inducer (such as but not limited to rifampin, carbamazepine, St. John's Wort, etc)
  14. Have a condition or a situation that in the Investigator's opinion may put the subject at increased risk, confound study data or interfere significantly with the subject's study participation, including but not limited to unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.
  15. Patient is using cyclosporine or tacrolimus for any condition and via any route of administration
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Oftac: 0.05% tacrolimus ophthalmic emulsion

    Drug: Oftac: 0.05% tacrolimus ophthalmic emulsion

Interventions

  • DrugOftac: 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.

06

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: 6 weeks

  2. Change in Best Corrected Visual Acuity (BCVA)

    Time frame: 6 weeks

  3. Change in Intraocular Pressure (IOP)

    Time frame: 6 weeks

Secondary outcomes

  1. Maximal plasma tacrolimus concentrations (Cmax)

    Time frame: 6 weeks

07

Study locations

7 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07869953
Lead sponsor
BioNanoSim Ltd.
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Mar 7, 2024
Primary completion
Mar 25, 2025
Completion
Mar 25, 2025
Last update
Oct 13, 2026

Study contacts

Michal Kramer, MD
principal investigator · Department of Ophthalmology, Rabin Medical Center, Petach Tikva, Israel, and Gray Faculty of Medical & Health Sciences, Tel Aviv University, Tel Aviv, Israel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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