NCT07285070

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

A Phase 2, Randomized, Double-Masked, Controlled, Proof-of-Concept Study to Evaluate the Safety and Biological Activity of a Water-free Tacrolimus Ophthalmic Solution (NOV05) for the Treatment of Non-Infectious Anterior Uveitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Novaliq GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Non-infectious Anterior Uveitis

Interventions

Type	Name	Description
DRUG	Tacrolimus ophthalmic solution	high and low dose treatment will be compared over 6 weeks treatment

Timeline

• Start date: 2026-03-16
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-12-16
• Last updated: 2026-04-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study