Tacrolimus Eye Drops for Anterior Uveitis
(EYETAC 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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NOV05 eye drops at two concentrations for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novaliq GmbH
Lead Sponsor
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- ...
5.
ophthalmologyadvisor.com
ophthalmologyadvisor.com/news/tacrolimus-effective-as-second-immunosuppressant-for-noninfectious-uveitis/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.
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