A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with Restyalne Defyne and the other eye injected with saline solution. Participants will be evaluated over four visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
14
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: 42 days after screening visit
Evaluating change in Ocular Surface Disease index (OSDI) score from baseline
Participants answer 12 question questionnaire. Scores from section I,II, and III
Time frame: 42 days after screening visit
Evaluating change in corneal staining score from baseline.
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: 42 days after screening visit
Evaluating Tear break-up time (TBUT) from baseline.
Performed by Keratograph 5M per manufacturer's directions.
Time frame: 42 days after screening visit
Evaluating tear meniscus height from baseline.
Performed by Keratograph 5M per manufacturer's directions.
Time frame: 42 days after screening visit.
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