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Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07285070

Phase 2 Study to Evaluate Safety of Two Doses of Tacrolimus Eye Drops for Treating Active Non-Infectious Anterior Uveitis

Led by Novaliq GmbH · Updated on 2026-07-28

20

Participants Needed

6

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and tolerability of NOV05, a water-free tacrolimus eye drop solution, in patients with active non-infectious anterior uveitis. This phase 2, randomized, double-masked study aims to test two concentrations of the eye drops over a 6-week treatment period to assess their safety and biological activity. Participants will be randomly assigned to receive either a high dose or a low dose of tacrolimus ophthalmic solution. The treatment is administered four times daily for six weeks. The study is conducted with quadruple masking to ensure unbiased results and is sponsored by Novaliq GmbH. During the study, participants will undergo regular monitoring for adverse events, with the primary outcome measured at 8 weeks. Safety and tolerability will be carefully assessed throughout the treatment period. Participants will be followed closely to evaluate any side effects and the overall biological activity of the treatment.

CONDITIONS

Brief Title

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

Research Team

A

Alice Meides, PhD

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