Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tacrolimus ophthalmic solution.
- Who it may be relevant to
- Registry conditions: Non-infectious Anterior Uveitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Tacrolimus ophthalmic solution
high and low dose treatment will be compared over 6 weeks treatment
Primary outcome measures
- Adverse Events [Time frame: 8 weeks]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Horizon Eye & Lasik Center — Phoenix
- Bascom Palmer Eye Institute — Miami
- Massachusetts Eye Research and Surgery Institution — Waltham
- Metropolitan Eye Research and Surgery Institute — Palisades Park
- Valley Retina Institute, P.A. — McAllen
- Virginia Eye Consultants — Norfolk
Identifiers
NCT: NCT07285070 · NOV05-001