March 2012
Volume 53, Issue 14
Free
ARVO Annual Meeting Abstract  |   March 2012
An Exploration of the Relationships between Tear Osmolarity and Other Measures of Dry Eye Signs and Symptoms
Author Affiliations & Notes
  • Yang Yang
    Global Clinical Development and Medical Affairs, Santen Inc., Emeryville, California
  • Marc Abrams
    Case Medical Center, University Hospital of Cleveland, Cleveland, Ohio
  • Will Garner
    Department of Mathematics, University of California at San Diego, San Diego, California
  • Michael Rinehart
    Global Clinical Development and Medical Affairs, Santen Inc., Emeryville, California
  • Becky P. Senic
    Global Clinical Development and Medical Affairs, Santen Inc., Emeryville, California
  • Hisao Shimada
    Global Clinical Development and Medical Affairs, Santen Inc., Emeryville, California
  • Mukta Tripathi
    Global Clinical Development and Medical Affairs, Santen Inc., Emeryville, California
  • Wei Liu
    Global Clinical Development and Medical Affairs, Santen Inc., Emeryville, California
  • Naveed Shams
    Global Clinical Development and Medical Affairs, Santen Inc., Emeryville, California
  • Footnotes
    Commercial Relationships  Yang Yang, None; Marc Abrams, None; Will Garner, None; Michael Rinehart, None; Becky P. Senic, None; Hisao Shimada, None; Mukta Tripathi, None; Wei Liu, None; Naveed Shams, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science March 2012, Vol.53, 548. doi:
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      Yang Yang, Marc Abrams, Will Garner, Michael Rinehart, Becky P. Senic, Hisao Shimada, Mukta Tripathi, Wei Liu, Naveed Shams; An Exploration of the Relationships between Tear Osmolarity and Other Measures of Dry Eye Signs and Symptoms. Invest. Ophthalmol. Vis. Sci. 2012;53(14):548.

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Abstract

Purpose: : To explore the relationships between tear osmolarity and other measures of dry eye signs and symptoms in subjects with moderate to severe dry eye disease.

Methods: : Tear osmolarity, Schirmer score, tear break-up time, total fluorescein corneal staining score, and symptoms (total ocular symptom score) were collected in a well-controlled, randomized, double-masked, multi-center study of 168 subjects with moderate to severe dry eye disease. The TearLab™ Osmolarity System was used to assess tear osmolarity at several visits. Pair-wise correlations between tear osmolarity and other efficacy measures at each visit were calculated for OD and OS, separately. The number of subjects involved in the correlation analysis varied by visit and ranged from 133 to 168.

Results: : Very weak correlations were found between tear osmolarity and Schirmer score (-0.16 to -0.05 for OD; -0.14 to -0.03 for OS), tear break-up time (-0.22 to 0.01 for OD; -0.24 to 0.12 for OS), total fluorescein corneal staining score (-0.02 to 0.19 for OD; and -0.01 to 0.17 for OS), and total ocular symptom score (-0.03 to 0.23 for OD; -0.02 to 0.06 for OS).

Conclusions: : Based on the weakness of the correlations seen, tear osmolarity alone, as measured in this study, may not be as helpful a tool as assumed. However, based on the directions of those correlations, in conjunction with other dry eye signs and symptoms, it could be used to confirm the diagnosis of dry eye disease.

Clinical Trial: : http://www.clinicaltrials.gov NCT01239069

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • clinical (human) or epidemiologic studies: biostatistics/epidemiology methodology • clinical (human) or epidemiologic studies: outcomes/complications 
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