In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients
Not Applicable
Completed
- Conditions
- Dry Eye Syndrome
- Interventions
- Other: SYSTANE® Gel Drop lubricant eye gel
- Registration Number
- NCT01483989
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.
- Detailed Description
The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
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)
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Exclusion Criteria
- 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SYSTANE® Gel Drops Lubricant eye gel SYSTANE® Gel Drop lubricant eye gel SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
- Primary Outcome Measures
Name Time Method Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel. baseline and 28 days The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
- Secondary Outcome Measures
Name Time Method