A Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi®
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dry Eye Syndromes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a national, prospective, multicenter, comparative, randomized, double-blinded non-inferiority study performed in two parallel groups.Masking: Double (Participant, Investigator)Masking Description: Double blindPrimary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The aim of the study is to demonstrate the non-inferiority of Eyestil Plus® compared to Vismed Multi® in terms of clinical performance as detected by a reduction of keratitis lesions objectified by staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with k...
The aim of the study is to demonstrate the non-inferiority of Eyestil Plus® compared to Vismed Multi® in terms of clinical performance as detected by a reduction of keratitis lesions objectified by staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with keratoconjunctivitis. Secondly, the study is aimed at evaluating the safety profile of the product and the patients' quality of life.
Tracking Information
- NCT #
- NCT03803748
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Pierre Jean Pisella, MD, Pr HOPITAL BRETONNEAU
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