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

NCT07285070 | Recruiting Phase 2 FDA Drug

• 1 other identifier: NOV05-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Non-infectious Anterior Uveitis

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  ocular and non-ocular adverse events

  8 weeks

Study Arms (2)

Tacrolimus ophthalmic solution (high dose)

ACTIVE COMPARATOR

Drug: Tacrolimus ophthalmic solution

Tacrolimus ophthalmic solution (low dose)

ACTIVE COMPARATOR

Drug: Tacrolimus ophthalmic solution

Interventions

Tacrolimus ophthalmic solution DRUG

high and low dose treatment will be compared over 6 weeks treatment

Tacrolimus ophthalmic solution (high dose); Tacrolimus ophthalmic solution (low dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Novaliq GmbH: lead

Study Sites (4)

Massachusetts Eye Research and Surgery Institution

Waltham, Massachusetts, 02451, United States

RECRUITING

Metropolitan Eye Research and Surgery Institute

Palisades Park, New Jersey, 07650, United States

RECRUITING

Valley Retina Institute, P.A.

McAllen, Texas, 78503, United States

RECRUITING

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

RECRUITING

Study Officials

• Sonja Kroesser, PhD

  Novaliq GmbH

  STUDY DIRECTOR

Central Study Contacts

Alice Meides, PhD

CONTACT

+49 622150259; ameides@novaliq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: March 16, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)