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Diurnal Variation of Tear Meniscus and Tear Osmolarity

This study has been completed.
Information provided by (Responsible Party):
Jianhua (Jay) Wang, MD, PhD, University of Miami Identifier:
First received: September 20, 2010
Last updated: June 11, 2013
Last verified: June 2013
This study is to determine the diurnal variation of tear meniscus and tear osmolarity in normal subjects and dry eye patients.

Dry Eye

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diurnal Variation of Tear Meniscus and Tear Osmolarity

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Variations in tear osmolarity and tear meniscus volume in patients with dry eyes and in healthy control subjects over an 8-hr daytime period. [ Time Frame: 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.

Enrollment: 20
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Normal subjects
Dry eye
clinically diagnosed dry eye with aqueous tear deficiency

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal subjects vs. dry eye patients

Inclusion criteria

  1. Is at least 18 years old and has full legal capacity to volunteer;
  2. Has read and signed the IRB Informed Consent Document;
  3. Is willing and able to follow participant instructions;
  4. Has clear corneas;
  5. Has 20/100 uncorrected visual acuity or better;
  6. Is not a hard (or rigid gas permeable) contact lens wearer within the last year;
  7. Was a soft contact lens wearer, but stopped wearing at least 1 week ago;
  8. Has dry eye according to the study definition of DES (study subjects).

Exclusion criteria

  1. Has any systemic disease affecting ocular health except for Sjögren's syndrome;
  2. Is using any systemic or topical medications that will affect ocular health except for artificial tears;
  3. Has an active ocular disease other than DES, meibomian gland disease or Sjögren's syndrome
  4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
  5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
  6. Has worn rigid gas permeable lenses within 1 year;
  7. Has had surgery or an eye injury within 6 months.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01206244

United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Principal Investigator: Jianhua Wang, MD, PhD University of Miami
  More Information

Responsible Party: Jianhua (Jay) Wang, MD, PhD, Associate Professor, University of Miami Identifier: NCT01206244     History of Changes
Other Study ID Numbers: UM20100465
Study First Received: September 20, 2010
Last Updated: June 11, 2013

Keywords provided by University of Miami:
dry eye
tear meniscus
tear osmolarity processed this record on April 28, 2017