Diurnal Variation of Tear Meniscus and Tear Osmolarity

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Jianhua (Jay) Wang, MD, PhD, University of Miami
ClinicalTrials.gov Identifier:
NCT01206244
First received: September 20, 2010
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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


Condition
Dry Eye

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

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 ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
Normal
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal subjects vs. dry eye patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206244

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

No publications provided

Responsible Party: Jianhua (Jay) Wang, MD, PhD, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01206244     History of Changes
Other Study ID Numbers: UM20100465
Study First Received: September 20, 2010
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
dry eye
tear meniscus
tear osmolarity

ClinicalTrials.gov processed this record on October 23, 2014