NCT04701086

3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis

A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study to Compare the Efficacy & Tolerability of CATIONORM PRO® & VISMED® in Patients With Mod-to-severe Dry Eye Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain. The patients will be randomised to receive Cationorm Pro® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion

Detailed description

Primary: • To compare the ocular efficacy of Cationorm Pro® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis after a 4-week treatment period (Day 28). Secondary: To compare the ocular efficacy of Cationorm Pro® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis over a 12-week treatment period To evaluate the ocular tolerability and safety of Cationorm Pro® versus VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis throughout the duration of treatment

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	Cationorm Pro	Eye Drops
DEVICE	Vismed	Eye Drops

Timeline

• Start date: 2021-09-30
• Primary completion: 2025-04-28
• Completion: 2025-04-28
• First posted: 2021-01-08
• Last updated: 2025-05-21

Locations

8 sites across 3 countries: France, Poland, Spain