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
Novaliq GmbH
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 uv…
Interventions
- DrugTacrolimus ophthalmic solution
high and low dose treatment will be compared over 6 weeks treatment
Locations (4)
- Massachusetts Eye Research and Surgery InstitutionWaltham, Massachusetts
- Metropolitan Eye Research and Surgery InstitutePalisades Park, New Jersey
- Valley Retina Institute, P.A.McAllen, Texas
- Virginia Eye ConsultantsNorfolk, Virginia