Non-infectious Anterior UveitisPhase 2EYETACNCT07285070
Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
A Phase 2 study testing Tacrolimus ophthalmic solution in people with Non-infectious Anterior Uveitis, run by Novaliq GmbH at 6 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-infectious Anterior Uveitis
- What is being tested?
- Tacrolimus ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Mar 2026to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥18 years of age;
- Provide written informed consent;
- Be diagnosed with active non-infectious anterior uveitis requiring initiation or increase of topical steroids administration for the management of ocular inflammation;
- Have an onset of symptoms within 4 weeks;
Who cannot join
- 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 malignancy;
- 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;
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Valley Retina Institute, P.A.
McAllen, Texas, 78503
Alexia Salas, +1 956-631-8875 ext. 1802
- Recruiting
Bascom Palmer Eye Institute
Miami, Florida, 33136
Javier Paredes, 305-326-6387, jxp2537@med.miami.edu
- Recruiting
Virginia Eye Consultants
Norfolk, Virginia, 23502
Alexandria Robinson, +1 757-493-3053
- Recruiting
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, 07650
Study Coordinator, +1 201-461-3970 ext. 125
- Recruiting
Horizon Eye & Lasik Center
Phoenix, Arizona, 85004
Study Coordinator, hello@doctrials.com
- Recruiting
Massachusetts Eye Research and Surgery Institution
Waltham, Massachusetts, 02451
Study Coordinator, +1 781-647-1431 ext. 402
About this study
Official title: A Phase 2, Randomized, Double-Masked, Controlled, Proof-of-Concept Study to Evaluate the Safety and Biological Activity of a Water-free Tacrolimus Ophthalmic Solution (NOV05) for the Treatment of Non-Infectious Anterior Uveitis
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.
- Conditions
- Non-infectious Anterior Uveitis
- Being tested
- Tacrolimus ophthalmic solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus ophthalmic solutionDrug
high and low dose treatment will be compared over 6 weeks treatment
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus ophthalmic solution (high dose) | Active comparator | Not described Receives: Drug: Tacrolimus ophthalmic solution |
| Tacrolimus ophthalmic solution (low dose) | Active comparator | Not described Receives: Drug: Tacrolimus ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
ocular and non-ocular adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start16 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious Anterior UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novaliq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonja Kroesser, PhD, Study director, Novaliq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285070
- Sponsor's protocol ID
- NOV05-001
- Acronym
- EYETAC
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Masked, Controlled, Proof-of-Concept Study to Evaluate the Safety and Biological Activity of a Water-free Tacrolimus Ophthalmic Solution (NOV05) for the Treatment of Non-Infectious Anterior Uveitis
- ClinicalTrials.gov ID
- NCT07285070
- Acronym / sponsor ID
- EYETAC / NOV05-001
- Conditions
- Non-infectious Anterior Uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Novaliq GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus ophthalmic solution (high dose) | Active comparator | Drug: Tacrolimus ophthalmic solution |
| Tacrolimus ophthalmic solution (low dose) | Active comparator | Drug: Tacrolimus ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be ≥18 years of age;
- Provide written informed consent;
- Be diagnosed with active non-infectious anterior uveitis requiring initiation or increase of topical steroids administration for the management of ocular inflammation;
- Have an onset of symptoms within 4 weeks;
Key exclusion criteria (7 listed)
- 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 malignancy;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus ophthalmic solutionhigh and low dose treatment will be compared over 6 weeks treatment | Drug | Tacrolimus ophthalmic solution (high dose), Tacrolimus ophthalmic solution (low dose) |
Primary outcome
Adverse Events
Time frame: 8 weeks
ocular and non-ocular adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonja Kroesser, PhD study director
Novaliq GmbH
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus ophthalmic solution in people with Non-infectious Anterior Uveitis, run by Novaliq GmbH at 6 sites in United States.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Meides, PhD (+49 622150259 ext. 0, ameides@novaliq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.