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 ]
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