3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dry Eye Syndromes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: PROSPECTIVE, MULTICENTRE, INVESTIGATOR-MASKED, PARALLEL-GROUP, ACTIVE-CONTROLLED, RANDOMISED, NON-INFERIORITY STUDYMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Investigator Masked, unmasked PharmacistPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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
Tracking Information
- NCT #
- NCT04701086
- Collaborators
- Not Provided
- Investigators
- Not Provided