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Diagnostic Evaluation of the Tear Film

Analysis of the Tear Film Lipid Layer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00761917
Enrollment
229
Registered
2008-09-30
Start date
2008-06-30
Completion date
2008-11-30
Last updated
2015-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

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.

Interventions

DEVICETear Film Analyzer

tear film images

Sponsors

TearScience, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Tear film analysis of lipid layer qualityupon enrollment

Secondary

MeasureTime frame
Dry Eye Symptomsupon enrollment
Tear Film Break-Up Timeupon enrollment
Corneal and Conjunctival Stainingupon enrollment
Meibomian Gland Assessmentupon enrollment
Schirmer Testupon enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026