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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Defyne recipient | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Defyne | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating change in Schirmer score from baseline. | Maximum length of tears absorbed on test strips recorded. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating change in OSDI score. | Participants answer 12 question questionnaire. Scores from section I,II, and III. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C Meyer, MD | The Eye Care Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| 30 Days |
| Evaluating change in dye disappearance test. | 30 days |
| Evaluating change in tear break-up time. | Performed by Keratograph 5M per manufacturer's directions. | 30 days |
| Evaluating change in tear meniscus height. | Performed by Keratograph 5M per manufacturer's directions. | 30 days |