20 Participants NeededMy employer runs this trial

Tacrolimus Eye Drops for Anterior Uveitis

(EYETAC Trial)

Recruiting at 5 trial locations
AM
Overseen ByAlice Meides, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Novaliq GmbH
Must be taking: Topical steroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and tolerability of tacrolimus eye drops (tacrolimus ophthalmic solution) for treating active non-infectious anterior uveitis, an inflammation in the front part of the eye. Researchers will test two different strengths of the eye drops to determine which is more effective. These eye drops may benefit individuals who have experienced symptoms of non-infectious anterior uveitis within the last four weeks and require initiation or escalation of steroid eye drop treatment to manage inflammation. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that Tacrolimus eye drops are likely to be safe for humans?

Research has shown that tacrolimus eye drops are generally safe for treating eye inflammation. Studies have demonstrated that tacrolimus effectively reduces inflammation in conditions like allergic conjunctivitis, which is similar to the focus of this trial on anterior uveitis. In several studies, patients used tacrolimus without major issues.

For instance, one study found that tacrolimus eye drops were well-tolerated by patients with allergic eye conditions. Another study showed that even a low concentration of tacrolimus eye drops reached effective levels in the eye, indicating it works without causing harm.

While these findings are encouraging, clinical trials are still ongoing to confirm safety specifically for anterior uveitis. However, based on current evidence, tacrolimus eye drops appear to be a safe option for many people with eye inflammation.12345

Why do researchers think this study treatment might be promising for anterior uveitis?

Unlike standard treatments for anterior uveitis, which typically involve corticosteroids, Tacrolimus eye drops offer a unique approach by using an immunosuppressant that targets T-cells to reduce inflammation. This treatment is exciting because it might minimize steroid-related side effects, such as increased eye pressure and cataracts, which are common with long-term steroid use. Additionally, the trial explores both low and high doses, potentially offering tailored options for different levels of disease severity. Researchers are hopeful that this alternative could provide a safer and equally effective option for managing anterior uveitis.

What evidence suggests that Tacrolimus Ophthalmic Solution might be an effective treatment for anterior uveitis?

Research has shown that tacrolimus eye drops may help treat anterior uveitis, an inflammation in the eye. This trial will compare different dosages of tacrolimus ophthalmic solution. Studies have found that tacrolimus effectively reduces inflammation in various eye conditions, including non-infectious uveitis. In one study, 65.6% of people with active uveitis experienced improvement, with their condition becoming inactive, often within 1.5 months of using tacrolimus. Additionally, tacrolimus has successfully treated other inflammatory eye diseases, indicating its potential to control inflammation more broadly. Tacrolimus is known for its strong ability to suppress the immune system, which helps reduce the immune response that causes eye inflammation.13678

Who Is on the Research Team?

SK

Sonja Kroesser, PhD

Principal Investigator

Novaliq GmbH

Are You a Good Fit for This Trial?

This trial is for adults (18+) with active non-infectious anterior uveitis that started within the last 4 weeks and who need to start or increase steroid eye drops. People can't join if they have infectious uveitis, severe eye problems, certain allergies, are pregnant/nursing, or have trouble following study instructions.

Inclusion Criteria

My symptoms started within the last 4 weeks.
Provide written informed consent
I am 18 years old or older.
See 1 more

Exclusion Criteria

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
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
I have active inflammation in the back part of my eye.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NOV05 eye drops at two concentrations for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tacrolimus Ophthalmic Solution

Trial Overview

The study is testing two strengths of tacrolimus eye drops (NOV05) used four times daily to see how safe and tolerable they are in treating active non-infectious anterior uveitis.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Tacrolimus ophthalmic solution (low dose)Active Control1 Intervention
Group II: Tacrolimus ophthalmic solution (high dose)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novaliq GmbH

Lead Sponsor

Trials
12
Recruited
2,300+

Citations

Clinical applications of tacrolimus in the treatment of ocular ...

It was among the first immunosuppressants of macrolide family recognized and was found to be highly effective immunosuppressive in vitro [3].

A Low Concentration of Tacrolimus/Semifluorinated Alkane ...

Results: The 0.03% Tacrolimus/SFA eyedrop treatment reduced the clinical scores and histological scores of intraocular inflammation in both EIU and EAU to the ...

Aqueous penetration of topical tacrolimus

7, 8, 9 Topical tacrolimus was found to be effective in inhibiting endotoxin-induced uveitis and autoimmune uveitis in experimental uveitis models., Topical use ...

Study Details | NCT07285070 | Tacrolimus Ophthalmic ...

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- ...

Tacrolimus Effective as Second Immunosuppressant for ...

When participants began taking tacrolimus, 65.6% presented active uveitis. Upon treatment, median time to inactive disease was 1.5 months (95% ...

Long-term outcomes of 0.1% tacrolimus eye drops in ... - PMC

The total score of clinical signs significantly decreased after 2 weeks and remained effective thereafter. Tacrolimus eye drops elicited a ...

Clinical Effectiveness, Safety, and Compliance of Two ...

The aim of this study is to evaluate and compare the effectivity, safety, and compliance of 0.015% tacrolimus eye drops with HPβCD (TCD) and the ...

Tacrolimus safe, effective for severe allergic conjunctivitis

This prospective study found that tacrolimus eye drops are highly effective at treating refractory allergic conjunctivitis with proliferative lesions.