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

ArmDescriptionAssigned Intervention
Active Comparator
Tacrolimus ophthalmic solution (high dose)
  • Drug: Tacrolimus ophthalmic solution
    high and low dose treatment will be compared over 6 weeks treatment
Active Comparator
Tacrolimus ophthalmic solution (low dose)
  • Drug: Tacrolimus ophthalmic solution
    high and low dose treatment will be compared over 6 weeks treatment

Recruiting Locations

Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey 07650

Valley Retina Institute, P.A.
McAllen, Texas 78503

Virginia Eye Consultants
Norfolk, Virginia 23502

More Details

Status
Recruiting
Sponsor
Novaliq GmbH

Study Contact

Alice Meides, PhD
+49 622150259
ameides@novaliq.com

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.