Moderate to Severe Dry Eye
Conditions
Keywords
Systane, Dry Eye
Brief summary
This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.
Detailed description
This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.
Interventions
OTHERSystane
Systane Lubricant Eye Drops \[1-2 Drops in each eye four times daily (QID)\]
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
* 18 years of age or older, of both sexes, and any race. * Willing and able to make all required visits and follow study instructions. * A sodium fluorescein corneal staining sum of \>/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart
Exclusion criteria
* A history or evidence of ocular or intraocular surgery in either eye within the past 6 months. * Lasik patients can be included if Lasik surgery was \> 6 months prior to the initiation of the study. * A history of intolerance or hypersensitivity to any component of the study medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Staining | Visit 2 (Week 2) - change from baseline |
| Best-corrected visual acuity | Visit 2 (Week 2) - change from baseline |
Outcome results
None listed