3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
NCT04701086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2025-05-21
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
Conditions
- Dry Eye Syndromes
Interventions
- DEVICE
-
Cationorm Pro
Eye Drops
- DEVICE
-
Vismed
Eye Drops
Sponsors & Collaborators
-
Santen SAS
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-30
- Primary Completion
- 2025-04-28
- Completion
- 2025-04-28
Countries
- France
- Poland
- Spain
Study Locations
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