In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients
1 other identifier
interventional
19
0 countries
N/A
Brief Summary
The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 29, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedNovember 18, 2016
February 1, 2012
4 months
November 29, 2011
November 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
baseline and 28 days
Study Arms (1)
SYSTANE® Gel Drops Lubricant eye gel
EXPERIMENTALSYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
Interventions
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
Eligibility Criteria
You may qualify if:
- Subjects must have history of dry eye as determined by:
- Questionnaire
- Tear Film Break Up Time less than or equal to 10 seconds
- Schirmer's score of less than or equal to 5 mm
- Corneal staining greater than or equal to 3 in either eye, and
- Positive for conjunctival staining (greater than or equal to 1)
You may not qualify if:
- Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Related Publications (1)
http://iovs.arvojournals.org/article.aspx?articleid=2351788
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2011
First Posted
December 2, 2011
Study Start
February 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
November 18, 2016
Record last verified: 2012-02