Clinical Trial

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

Study acronym: ALHENA
Active, Not Recruiting
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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
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-12-22; most recent amendment 2025-05-16.
Status change: Recruiting → Active, Not Recruiting 2025-05-16
Status change: Not Yet Recruiting → Recruiting 2021-05-18
Trial Details
NCT Number NCT04685109
Lead Sponsor Santen SAS
Conditions Dry Eye Syndromes
Enrollment 80 participants
Start Date 2021-05-11
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-21