Diagnostic Evaluation of the Tear Film

Dry Eye Syndromes Clinical Trial

Official title:

Analysis of the Tear Film Lipid Layer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761917
• Other study ID #: KS010
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: March 30, 2015
• Start date: June 2008
• Est. completion date: November 2008

Study information

• Verified date: March 2015
• Source: TearScience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The objectives of this study are to assess for a difference between normal and dry eye subjects in tear film quality using a diagnostic interferometry device and to determine whether there are associations between tear film quality and dry eye symptoms and signs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults 18 year of age or older

• Willing and able to comply with study exam procedure

Exclusion Criteria:

• Eyelid abnormality or ocular surface condition affecting ability to visualize tear film

• Women who are pregnant or nursing

• Any of the following conditions within specified timeframe prior to study participation:

1. Instillation of eye drops

2. Contact lens wear

3. Use of oil-based facial cosmetics

4. Swimming in chlorinated pool

5. Eye examination procedures that may affect the tear film

6. Participation in another ophthalmic clinical trial

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Tear Film Analyzer
tear film images

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TearScience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear film analysis of lipid layer quality		upon enrollment	No
Secondary	Dry Eye Symptoms		upon enrollment	No
Secondary	Tear Film Break-Up Time		upon enrollment	No
Secondary	Corneal and Conjunctival Staining		upon enrollment	No
Secondary	Meibomian Gland Assessment		upon enrollment	No
Secondary	Schirmer Test		upon enrollment	No