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Completed

NCT Number: NCT01206244

Diurnal Variation of Tear Meniscus and Tear Osmolarity

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Allergan

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 21, 2010
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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