Diagnostic Evaluation of the Tear Film
Completed
- Conditions
- Dry Eye Syndromes
- Interventions
- Device: Tear Film Analyzer
- Registration Number
- NCT00761917
- Lead Sponsor
- TearScience, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
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:
- Instillation of eye drops
- Contact lens wear
- Use of oil-based facial cosmetics
- Swimming in chlorinated pool
- Eye examination procedures that may affect the tear film
- Participation in another ophthalmic clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 2: Dry Eye Tear Film Analyzer Subjects with dry eye symptoms based on questionnaire. 1: Normal Tear Film Analyzer Subjects without dry eye symptoms based on questionnaire.
- Primary Outcome Measures
Name Time Method Tear film analysis of lipid layer quality upon enrollment
- Secondary Outcome Measures
Name Time Method Dry Eye Symptoms upon enrollment Corneal and Conjunctival Staining upon enrollment Tear Film Break-Up Time upon enrollment Meibomian Gland Assessment upon enrollment Schirmer Test upon enrollment