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Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

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

NCT07285070•Novaliq GmbH

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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;

Key Dates

Start Date

March 1, 2026

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

December 16, 2025

Enrollment

ESTIMATED participants

Conditions

Non-infectious Anterior Uveitis

Interventions

Tacrolimus ophthalmic solution

DRUG

Contacts

Alice Meides, PhD

CONTACT

+49 622150259 ameides@novaliq.com

A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

NCT04222712

Non-infectious Anterior Uveitis

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COMPLETEDPHASE3

A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

NCT05042609

Non-infectious Anterior UveitisUveitic Glaucoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis