Diurnal Variation of Tear Meniscus and Tear Osmolarity

Dry Eye Clinical Trial

Official title:

Diurnal Variation of Tear Meniscus and Tear Osmolarity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206244
• Other study ID #: UM20100465
• Status: Completed
• Phase: N/A
• First received: September 20, 2010
• Last updated: June 11, 2013
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No