Diurnal Variation of Tear Meniscus and Tear Osmolarity

NCT01206244 | Completed

• 1 other identifier: UM20100465
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Keywords

dry eye; tear meniscus; tear osmolarity

Outcome Measures

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.

  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.

  8 hours

Study Arms (2)

Normal

Normal subjects

Dry eye

clinically diagnosed dry eye with aqueous tear deficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal subjects vs. dry eye patients

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Allergan: collaborator

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Jianhua Wang, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 21, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

US (1)