Clinical Trial: Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz

Brief Summary: The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed to controlled adverse environmental conditions.

Detailed Summary:
Sponsor: Instituto Universitario de Oftalmobiología Aplicada

Current Primary Outcome: Proportion of patients with fluorescein corneal staining reduction of at least 1 point [ Time Frame: 1 Month ]

Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Best Corrected Visual Acuity [ Time Frame: 1 month ]
    Best Corrected Visual Acuity at Exit visit compared to baseline visit
  • Intraocular pressure [ Time Frame: 1 month ]
    Pathological elevations of intraocular pressure from baseline
  • Eye fundus alterations [ Time Frame: 1 month ]
    Presence of any pathological finding in eye fundus while the patient is in the study
  • Corneal Pachymetry [ Time Frame: 1 month ]
    Changes in corneal thickness along the study


Original Secondary Outcome: Same as current

Information By: Instituto Universitario de Oftalmobiología Aplicada

Dates:
Date Received: December 4, 2012
Date Started: December 2012
Date Completion:
Last Updated: January 7, 2015
Last Verified: January 2015