Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis
Purpose
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.
Condition
- Non-infectious Anterior Uveitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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;
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Tacrolimus ophthalmic solution (high dose) |
|
|
|
Active Comparator Tacrolimus ophthalmic solution (low dose) |
|
Recruiting Locations
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey 07650
Palisades Park, New Jersey 07650
Valley Retina Institute, P.A.
McAllen, Texas 78503
McAllen, Texas 78503
Virginia Eye Consultants
Norfolk, Virginia 23502
Norfolk, Virginia 23502
More Details
- Status
- Recruiting
- Sponsor
- Novaliq GmbH
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.