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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    80
  • sponsor
    Santen SAS
Updated on 24 June 2021
Investigator
Julia L Martin, BSc
Primary Contact
Chru Brest Hopital Morvan (0.4 mi away) Contact
+9 other location

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

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

Details
Condition Dry eye syndrome, Keratoconjunctivitis Sicca, Dry Eyes, dry eye
Treatment Alocross 0.2% Unit Dose, Vismed
Clinical Study IdentifierNCT04685109
SponsorSanten SAS
Last Modified on24 June 2021

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