A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. Participants will be evaluated over four visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
17
Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL.
The Eye Care Institute
Louisville, Kentucky, United States
Evaluating change in Schirmer score from baseline.
Maximum length of tears absorbed on test strips recorded.
Time frame: 30 days
Evaluating change in OSDI score.
Participants answer 12 question questionnaire. Scores from section I,II, and III.
Time frame: 30 Days
Evaluating change in corneal staining score.
1.0mg sodium fluorescein strips on lower eye lids for one minute. 5 corneal regions graded using cobalt filter to maximized view of fluorescence.
Time frame: 30 Days
Evaluating change in dye disappearance test.
Time frame: 30 days
Evaluating change in tear break-up time.
Performed by Keratograph 5M per manufacturer's directions.
Time frame: 30 days
Evaluating change in tear meniscus height.
Performed by Keratograph 5M per manufacturer's directions.
Time frame: 30 days
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