Diagnostic Evaluation of the Tear Film

N/ACompletedNCT00761917

TearScience, Inc.229 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

229

Conditions

Dry Eye Syndromes

Interventions

Tear Film AnalyzerDEVICE

tear film images

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Fayetteville, Arkansas, United States

Unnamed facility

Morrow, Georgia, United States

Unnamed facility

Oak Lawn, Illinois, United States

Unnamed facility

Edgewood, Kentucky, United States

Outcomes

Primary Outcomes

Tear film analysis of lipid layer quality

Time frame: upon enrollment

Secondary Outcomes

Dry Eye Symptoms

Time frame: upon enrollment

Tear Film Break-Up Time

Time frame: upon enrollment

Corneal and Conjunctival Staining

Time frame: upon enrollment

Meibomian Gland Assessment

Time frame: upon enrollment

Schirmer Test

Time frame: upon enrollment

Data from ClinicalTrials.gov

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