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Non-Infectious Anterior UveitisPhase 1/2NCT07869953

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

A Phase 1/2 study testing Oftac: 0.05% tacrolimus ophthalmic emulsion in people with Non-Infectious Anterior Uveitis, run by BioNanoSim Ltd. at 7 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Infectious Anterior Uveitis
What is being tested?
Oftac: 0.05% tacrolimus ophthalmic emulsion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
7 sitesIsrael
Study dates
7 Mar 2024to 25 Mar 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to provide written informed consent
  • Able and willing to follow all study instructions, restrictions and attend study visits
  • Male and female patients 18 to 70 years of age
  • 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)
  • BCVA equal or better than 0.3 Log MAR in the non-investigated eye.

Who cannot join

  • Be a female of childbearing potential who is currently pregnant, nursing, or planning to become pregnant or nurse during the study
  • Have known contraindications or a sensitivity to any of the study drugs or excipients
  • Have an active ocular infection (bacterial, viral, or fungal)
  • Have active non-uveitic ocular inflammation (e.g., severe blepharitis, any active allergic conjunctivitis, peripheral ulcerative keratitis or scleritis) in either eye
  • Have a known history or diagnosis of ocular herpes-simplex infection
  • Have active posterior-uveitis and/or active intermediate uveitis or any other form of active uveitis aside from anterior uveitis
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  • Have a history of old posterior uveitis, or scars or intermediate uveitis that was active during the last six months
  • Have chronic Anterior Chamber (AC) flare >/= +3.
  • Plan to have any form of eye surgery within the study period or less than 3 months prior to screening
  • Have high myopia (above 9 diopters) or astigmatism (above 4 diopters) in the study eye
  • 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
  • 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.
  • Patient is using a cytochrome P450-3A4 inhibitor inducer (such as but not limited to rifampin, carbamazepine, St. John's Wort, etc)
  • 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.
  • Patient is using cyclosporine or tacrolimus for any condition and via any route of administration

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Israel7 sites

  • Department of Ophthalmology, Soroka University Medical Center, Ben-Gurion University of the Negev

    Beersheba

  • Department of Ophthalmology, Bnai Zion Medical Center

    Haifa

  • Department of Ophthalmology, Carmel Medical Center, The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology

    Haifa

  • Department of Ophthalmology, Rambam Medical Center, The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Israel Institute of Technology

    Haifa

  • Department of Ophthalmology, Hadassah Medical Organization and Faculty of Medicine, Hebrew University of Jerusalem

    Jerusalem

  • Department of Ophthalmology, Rabin Medical Center

    Petah Tikva

  • Shamir Medical Center

    Tsrifin

Other trials in Israel

About this study

Official title: A Multicenter, Open Label Phase-1/2a Study of Oftac Eye Drops in Active Non-Infectious Anterior Uveitis Patients

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.

Being tested
Oftac: 0.05% tacrolimus ophthalmic emulsion
Keywords
Uveitis, Best Corrected Visual Acuity, Intraocular Pressure, Tacrolimus Ophthalmic emulsion, Topical Tacrolimus
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oftac: 0.05% tacrolimus ophthalmic emulsionDrug

    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.

Study groups in NCT07869953
Study groupRoleWhat they receive
Oftac: 0.05% tacrolimus ophthalmic emulsionExperimentalNot described
Receives: Drug: Oftac: 0.05% tacrolimus ophthalmic emulsion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Measured: 6 weeks

  2. Change in Best Corrected Visual Acuity (BCVA)

    Measured: 6 weeks

  3. Change in Intraocular Pressure (IOP)

    Measured: 6 weeks

Secondary outcomes (1)

  1. Maximal plasma tacrolimus concentrations (Cmax)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2026
  2. Study start7 Mar 2024
  3. Primary completion25 Mar 2025
  4. Study completion25 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07869953
Sponsor's protocol ID
BNS-CL-01
Other IDs
MOH_2022-09-08_012035
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oftac: 0.05% tacrolimus ophthalmic emulsion in people with Non-Infectious Anterior Uveitis, run by BioNanoSim Ltd. at 7 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07869953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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