NCT02585453

Influence of Lachrymal Substitute Gels on Tear Film Thickness in Patients With Moderate to Severe Dry Eye Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, exact information about the tear film thickness and the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found. Recently a new method for assessment of tear film thickness based on ultra high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess tear film thickness and corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane® Gel Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	Thealoz Duo Gel	Manufacturer: Laboratoires Thea, France
DEVICE	Hylo-Gel	Manufacturer: Ursapharm, Saarbrücken, Germany
DEVICE	Systane Gel Drops	Manufacturer: Alcon Pharma GmbH, Fort Worth, TX, USA

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2015-10-23
• Last updated: 2015-12-03

Locations

1 site across 1 country: Austria