NCT01176045

TearLab Refractive Surgery Dry Eye Study

Measurement of Refractive Surgery Induced Dry Eye Using Tear Osmolarity Testing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 128 (actual)
• Sponsor: TearLab Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine how pre \& post-operative tear osmolarity levels relate to rates of dry eye symptoms related to refractive surgery and if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively.

Detailed description

Dry eye disease is a common and major source of disability, whether occurring as a primary disorder or as a component of other diseases and its onset may be triggered or modified by exposure to systemic drugs, contact lens wear, ocular surgery and adverse environmental and work conditions. The development of a reliable, highly sensitive and specific test for the clinical diagnosis of dry eye is a major unmet clinical need, particularly to differentiate it from common conditions such as ocular allergy which exhibit similar presenting symptoms. Tear hyper-osmolarity is central to the dry eye disease process and the measurement of tear osmolarity could serve not only as a highly accurate diagnostic test but also as a measure of disease severity and a means to monitor treatment efficacy. Recently, there have been reports in the literature regarding dry eye disease; both early and chronic following refractive surgery, with many cases potentially being previously inadvertently undiagnosed dry eye disease.

Conditions

• Dry Eye Syndromes

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-08-05
• Last updated: 2016-02-04

Locations

8 sites across 1 country: United States