Actively Recruiting
Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
Led by Novaliq GmbH · Updated on 2026-04-16
20
Participants Needed
4
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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;
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Massachusetts Eye Research and Surgery Institution
Waltham, Massachusetts, United States, 02451
Actively Recruiting
2
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States, 07650
Actively Recruiting
3
Valley Retina Institute, P.A.
McAllen, Texas, United States, 78503
Actively Recruiting
4
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
A
Alice Meides, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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