Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
Recruiting now · Phase 2
Conditions studied: Non-infectious Anterior Uveitis
In brief
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.
Key facts
- Study ID
- NCT07285070
- Run by
- Novaliq GmbH
- People needed
- 20
- Starts
- 2026-03-16
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
Where it is running
- Horizon Eye & Lasik Center — Phoenix, Arizona, United States (enrolling)
- Bascom Palmer Eye Institute — Miami, Florida, United States (enrolling)
- Massachusetts Eye Research and Surgery Institution — Waltham, Massachusetts, United States (enrolling)
- Metropolitan Eye Research and Surgery Institute — Palisades Park, New Jersey, United States (enrolling)
- Valley Retina Institute, P.A. — McAllen, Texas, United States (enrolling)
- Virginia Eye Consultants — Norfolk, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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