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

NCT ID: NCT07285070

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Non-infectious Anterior Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tacrolimus ophthalmic solution (high dose)

Group Type ACTIVE_COMPARATOR

Tacrolimus ophthalmic solution

Intervention Type DRUG

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

Tacrolimus ophthalmic solution (low dose)

Group Type ACTIVE_COMPARATOR

Tacrolimus ophthalmic solution

Intervention Type DRUG

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

Interventions

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Tacrolimus ophthalmic solution

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

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novaliq GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonja Kroesser, PhD

Role: STUDY_DIRECTOR

Novaliq GmbH

Central Contacts

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Alice Meides, PhD

Role: CONTACT

[email protected]
+49 622150259 ext. 0

Other Identifiers

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NOV05-001

Identifier Type: -

Identifier Source: org_study_id