Diurnal Variation of Tear Meniscus and Tear Osmolarity

Completed

• Conditions: Dry Eye

• Registration Number: NCT01206244
• Lead Sponsor: University of Miami

Brief Summary

This study is to determine the diurnal variation of tear meniscus and tear osmolarity in normal subjects and dry eye patients.

Detailed Description

This study is to determine the diurnal variation of tear meniscus using OCT and tear osmolarity using Tearlab's osmolarity system in normal subjects and dry eye patients.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variations in tear osmolarity and tear meniscus volume in patients with dry eyes and in healthy control subjects over an 8-hr daytime period.	8 hours	The mean tear osmolarity of the dry eye patients was 304.0±10.8 mOsm/L, and the mean tear osmolarity of the normal subjects was 298.0±14.2 mOsm/L (P.0.05). Over the course of 8 hrs, the average measured osmolarities of the dry eye group varied by approximately 21.9±13.5 mOsm/L (range, 6-43 mOsm/L), and the average measured tear osmolarities of the normal group varied by approximately 21.0±9.2 mOsm/L (range, 8-35 mOsm/L). At 2:30 PM, the average volume of the tear menisci in the dry eye group was significantly lower than that of the subjects in the normal group (P,0.05). No correlations between the tear meniscus volumes and tear osmolarities of either group were observed.

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States