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Active, not recruitingNCT07285070EYETACUpdated Nov 9, 2026

Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis

A Phase 2 interventional study of Tacrolimus ophthalmic solution in Non-infectious Anterior Uveitis, sponsored by Novaliq GmbH. Active, not recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Novaliq GmbH · Phase 2, Interventional, and Treatment

Updated Nov 9, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Uveitis, Anterior with a site in United States — 5 open to participants now, 6 under way, none of them phase 3. Uveitis, Anterior · United States.

Planned enrollment
17th of 27
20 · median 40
Started
2026
with 3 others
Phase 2
6 of 30
1 open now
Registered
28th of 30
by date

Among the 30 studies in Uveitis, Anterior with a site in United States, this one is the 17th largest by planned enrollment of the 27 interventional ones, is one of 4 that started in 2026, is one of 6 in phase 2, and was the 28th registered.

By phase

30 studies; the count open now beside each. This study's row is marked.

Phase 39 · 0 open
Phase 2this study6 · 1 open
Phase 44 · 3 open
Observational3 · 1 open
Phase 1/23 · 0 open
No phase2 · 0 open
Phase 2/32 · 0 open
Phase 11 · 0 open

By the year they started

First in 2005; this study’s year is marked. 4 started in 2026.

Size and results

Median enrollment 40 across the 27 interventional studies, 50 across the 3 observational. Of the 23 that completed or were terminated, 15 (65%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 30 studies in Uveitis, Anterior with a site in United States, or all of them as a file.
02

Study summary

The primary objective of the study is to investigate the safety and tolerability of NOV05 eye drops at two concentrations QID in patients with active non-infectious anterior uveitis.

Read the detailed description

This first in-human, phase 2 proof of concept study aims to show that the formulation at two concentrations is safe and well tolerated over a period of 6 weeks.

03

Conditions studied

  • Non-infectious Anterior Uveitis

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
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

  • Be ≥18 years of age;
  • Provide written ;
  • Be diagnosed with active non-infectious anterior uveitis requiring initiation or increase of topical administration for the management of ocular inflammation;
  • Have an onset of symptoms within 4 weeks;

Exclusion criteria

Exclusion Criteria:

  • Have severe/serious ocular pathology in the study eye which may preclude study completion or interferes with trial assessment, in the judgement of the clinical Investigator;
  • Have a history of or a current ocular or periocular ;
  • Have active intermediate or posterior uveitis in the study eye or another documented posterior segment inflammation;
  • A confirmed or highly suspicious infectious uveitis eg, CMV, Herpes simplex, Herpes zoster, syphilis, tuberculosis, lyme disease;
  • Have a known allergy or sensitivity to the IMP tacrolimus or semifluorinated alkanes (SFA);
  • Be a woman who is pregnant, nursing, or planning a pregnancy;
  • Have a condition or be in a situation (e.g. language barrier, non-cooperative, history of substance abuse) which the Investigator considers that it may put the patient at significant risk, may confound the trial results, or may significantly interfere with the patient's participation in the trial;
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Tacrolimus ophthalmic solution (high dose)

    Drug: Tacrolimus ophthalmic solution

  • Active comparator
    Tacrolimus ophthalmic solution (low dose)

    Drug: Tacrolimus ophthalmic solution

Interventions

06

What researchers measure

Primary outcomes

  1. Adverse Events

    ocular and non-ocular adverse events

    Time frame: 8 weeks

07

Study locations

6 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Oct 2026 → Dec 2026 and completion Oct 2026 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2025
First posted
Dec 16, 2025
StartActual
Mar 16, 2026
Primary completionEst.
Dec 2026was Oct 2026
CompletionEst.
Dec 2026was Oct 2026
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Nov 9, 2026
Primary completion
Oct 2026→Dec 2026
Nov 9, 2026
Study completion
Oct 2026→Dec 2026
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Recruiting→Active, not recruiting
    Primary completion Oct 2026→Dec 2026
    Study completion Oct 2026→Dec 2026
    + 2 other changes: contact details and site details

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
NCT07285070
Lead sponsor
Novaliq GmbH
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Mar 16, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 9, 2026

Study contacts

Sonja Kroesser, PhD
study director · Novaliq GmbH

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tacrolimus

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