Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis (EYETAC)

Novaliq

Status and phase

Begins enrollment this month

Phase 2

Conditions

Non-infectious Anterior Uveitis

Treatments

Drug: Tacrolimus ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT07285070

NOV05-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;