NCT04276558

REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients

Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.

Detailed description

This was a Phase 2, international, multicentre, dose-ranging, double-masked, randomised, parallel-group, vehicle-controlled study designed to evaluate 3 different doses of REC 0/0559 vs vehicle in patients with Stage 2 and Stage 3 neurotrophic keratitis (NK).

Conditions

• Neurotrophic Keratitis

Interventions

Type	Name	Description
DRUG	Udonitrectag	Eye drop solution in single dose unit.
OTHER	Vehicle	Eye drop solution with no active substance in single dose unit.

Timeline

• Start date: 2020-10-13
• Primary completion: 2024-04-29
• Completion: 2024-04-29
• First posted: 2020-02-19
• Last updated: 2025-05-14
• Results posted: 2025-05-14

Locations

41 sites across 7 countries: United States, France, Germany, Hungary, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study