Dry Eye Syndrome
Conditions
Keywords
Dry Eye, Epithelial changes
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.
Interventions
OTHERSYSTANE® Gel Drop lubricant eye gel
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must have history of dry eye as determined by: 1. Questionnaire 2. Tear Film Break Up Time less than or equal to 10 seconds 3. Schirmer's score of less than or equal to 5 mm 4. Corneal staining greater than or equal to 3 in either eye, and 5. Positive for conjunctival staining (greater than or equal to 1)
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed