NCT01753596

Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking. Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DEVICE	GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)
OTHER	Physiological Sodium Chloride solution (0,9%)	Placebo

Timeline

• Start date: 2014-12-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2012-12-20
• Last updated: 2014-11-14

Locations

1 site across 1 country: Austria