NCT04685109

3 Month Study of Alocross 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 in Adult Patients With Moderate to Severe Dry Eye Disease Related to Keratitis or Keratoconjunctivitis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• 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 conducted at a national level, in France. The patients will be randomised to receive ALOCROSS® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion

Detailed description

Primary: • To compare the ocular efficacy of ALOCROSS® 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 ALOCROSS® 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 ALOCROSS® 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	Alocross 0.2% Unit Dose	Eye Drops
DEVICE	Vismed	Eye drops

Timeline

• Start date: 2021-05-11
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2020-12-28
• Last updated: 2025-05-21

Locations

6 sites across 1 country: France