This study will be a randomized, double-blind prospective in 3 clinical sites to compare the efficacy of two currently approved topical ophthalmic drops in the clearing central corneal staining in 90 days prior to elective cataract or LASIK surgery.
The study will be a randomized, double-blind prospective study in 3 sites in the US to compare efficacy of improvement in central corneal staining with fluorescein dye evaluations at slit lamp exam, secondarily improvement in OSDI questionnaire with additional questions regarding dysgeusia, blurriness, and sensation of burning, improvements in corneal topography and improvements in Schirmer's testing. 100 study subjects 18-85 male or female will be enrolled in the Nashville, Beverly Hills and St. Louis areas who are generally healthy with central corneal staining and scheduled for uncomplicated phacoemulsification or uncomplicated LASIK.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
topical ophthalmic drop prior to elective surgery for eligible patients
topical ophthalmic drop prior to elective surgery for eligible patients
Toyos Clinic
Nashville, Tennessee, United States
RECRUITINGchange in central corneal staining
use of fluorescein staining to count at slit lamp actual number of central cornea spk
Time frame: 90 days
change in OSDI questionnaire with additional questions of dysgeusia, blurriness and sensation of burning
subjective improvement of symptoms and assessment of adverse events
Time frame: 90 days
change in corneal topography
variation in measurements of corneal topography
Time frame: 90 days
change in Schirmers testing
change in Schirmers testing
Time frame: 90 days
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