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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Defyne receiver | Experimental | Participants will receive Restyane Defyne injected into punctum of one eye. |
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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. | 42 days after screening visit |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating change in Ocular Surface Disease index (OSDI) score from baseline | Participants answer 12 question questionnaire. Scores from section I,II, and III | 42 days after screening visit |
| Evaluating change in corneal staining score from baseline. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2018 | Oct 15, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Study is set as a single-arm, randomized, single-masked to evaluate Restylane Defyne for canalicular occlusion in participants with mild to moderate dry eye disease. Each participant will have a screening visit, it is then participants will be provided with informed consent form to review and ask questions before written informed consent is obtained. Screening visit occurs 30 days prior to 42 days and will be seen for follow-up exams at 3 , 14 and 42 days.
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1.0mg sodium fluorescein strips on lower eye lids for one minute. 5 corneal regions graded using cobalt filter to maximized view of fluorescence.
| 42 days after screening visit |
| Evaluating Tear break-up time (TBUT) from baseline. | Performed by Keratograph 5M per manufacturer's directions. | 42 days after screening visit |
| Evaluating tear meniscus height from baseline. | Performed by Keratograph 5M per manufacturer's directions. | 42 days after screening visit. |