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
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Diurnal Variation of Tear Meniscus and Tear Osmolarity
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
clinically diagnosed dry eye with aqueous tear deficiency
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Normal subjects vs. dry eye patients
- Is at least 18 years old and has full legal capacity to volunteer;
- Has read and signed the IRB Informed Consent Document;
- Is willing and able to follow participant instructions;
- Has clear corneas;
- Has 20/100 uncorrected visual acuity or better;
- Is not a hard (or rigid gas permeable) contact lens wearer within the last year;
- Was a soft contact lens wearer, but stopped wearing at least 1 week ago;
- Has dry eye according to the study definition of DES (study subjects).
- Has any systemic disease affecting ocular health except for Sjögren's syndrome;
- Is using any systemic or topical medications that will affect ocular health except for artificial tears;
- Has an active ocular disease other than DES, meibomian gland disease or Sjögren's syndrome
- Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
- Has worn rigid gas permeable lenses within 1 year;
- Has had surgery or an eye injury within 6 months.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01206244
|Bascom Palmer Eye Institute
|Miami, Florida, United States, 33136 |
University of Miami
||Jianhua Wang, MD, PhD
||University of Miami
No publications provided
||Jianhua (Jay) Wang, MD, PhD, Associate Professor, University of Miami
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 20, 2010
||June 11, 2013
||United States: Food and Drug Administration
Keywords provided by University of Miami:
ClinicalTrials.gov processed this record on September 16, 2014