Recruiting
Phase 2

NOV05

Sponsor:

Novaliq GmbH

Code:

NCT07285070

Conditions

Non-infectious Anterior Uveitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tacrolimus ophthalmic solution

Study Details

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

Study ID

NCT07285070

Start date

Mar 16, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Tacrolimus ophthalmic solution (high dose)

active comparator: Tacrolimus ophthalmic solution (low dose)

Interventions

Tacrolimus ophthalmic solution

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

Primary outcome measure

  • Adverse Events [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Alice Meides, PhD

+49 622150259ameides@novaliq.com

Locations

Horizon Eye & Lasik Center

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Study Coordinator

hello@doctrials.com

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Javier Paredes

305-326-6387jxp2537@med.miami.edu

Massachusetts Eye Research and Surgery Institution

Recruiting

Waltham, Massachusetts, United States, 02451

Contacts

Study Coordinator

+1 781-647-1431

Metropolitan Eye Research and Surgery Institute

Recruiting

Palisades Park, New Jersey, United States, 07650

Contacts

Study Coordinator

+1 201-461-3970

Valley Retina Institute, P.A.

Recruiting

McAllen, Texas, United States, 78503

Contacts

Alexia Salas

+1 956-631-8875

Virginia Eye Consultants

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Alexandria Robinson

+1 757-493-3053

More Information

Sponsor

Novaliq GmbH

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novaliq GmbH on 2026-07-28.