Tacrolimus ophthalmic solution: high and low dose treatment will be compared over 6 weeks treatment
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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;
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 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;
Primary outcome measure(s)
Adverse Events — 8 weeks ocular and non-ocular adverse events
Trial sites (6)
Facility
City
Region
Status
Horizon Eye & Lasik Center
Phoenix
Arizona
Recruiting
Bascom Palmer Eye Institute
Miami
Florida
Recruiting
Massachusetts Eye Research and Surgery Institution
Waltham
Massachusetts
Recruiting
Metropolitan Eye Research and Surgery Institute
Palisades Park
New Jersey
Recruiting
Valley Retina Institute, P.A.
McAllen
Texas
Recruiting
Virginia Eye Consultants
Norfolk
Virginia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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