Diagnostic Evaluation of the Tear Film
Analysis of the Tear Film Lipid Layer
1 other identifier
observational
229
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedMarch 31, 2015
March 1, 2015
4 months
September 26, 2008
March 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Tear film analysis of lipid layer quality
upon enrollment
Secondary Outcomes (5)
Dry Eye Symptoms
upon enrollment
Tear Film Break-Up Time
upon enrollment
Corneal and Conjunctival Staining
upon enrollment
Meibomian Gland Assessment
upon enrollment
Schirmer Test
upon enrollment
Study Arms (2)
1: Normal
Subjects without dry eye symptoms based on questionnaire.
2: Dry Eye
Subjects with dry eye symptoms based on questionnaire.
Interventions
tear film images
Eligibility Criteria
Subjects undergoing routine eye examination in ophthalmic practices
You may qualify if:
- Adults 18 year of age or older
- Willing and able to comply with study exam procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Fayetteville, Arkansas, United States
Unknown Facility
Morrow, Georgia, United States
Unknown Facility
Oak Lawn, Illinois, United States
Unknown Facility
Edgewood, Kentucky, United States
Unknown Facility
Bloomington, Minnesota, United States
Unknown Facility
Chesterfield, Missouri, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Henderson, North Carolina, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christy Stevens, OD
Kolis Scientific
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
March 31, 2015
Record last verified: 2015-03