A Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion
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|ClinicalTrials.gov Identifier: NCT03709641|
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mild to Moderate Dry Eye Disease||Device: Restylane Defyne||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane Defyne for Canalicular Occlusion in Participants With Mild to Moderate Dry Eye Disease|
|Actual Study Start Date :||October 17, 2018|
|Actual Primary Completion Date :||November 28, 2018|
|Actual Study Completion Date :||November 28, 2018|
Experimental: Restylane Defyne receiver
Participants will receive Restyane Defyne injected into punctum of one eye.
Device: Restylane Defyne
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
- Evaluating change in Schirmer score from baseline [ Time Frame: 42 days after screening visit ]Maximum length of tears absorbed on test strips recorded.
- Evaluating change in Ocular Surface Disease index (OSDI) score from baseline [ Time Frame: 42 days after screening visit ]Participants answer 12 question questionnaire. Scores from section I,II, and III
- Evaluating change in corneal staining score from baseline. [ Time Frame: 42 days after screening visit ]1.0mg sodium fluorescein strips on lower eye lids for one minute. 5 corneal regions graded using cobalt filter to maximized view of fluorescence.
- Evaluating Tear break-up time (TBUT) from baseline. [ Time Frame: 42 days after screening visit ]Performed by Keratograph 5M per manufacturer's directions.
- Evaluating tear meniscus height from baseline. [ Time Frame: 42 days after screening visit. ]Performed by Keratograph 5M per manufacturer's directions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709641
|United States, Kentucky|
|The Eye Care Institute|
|Louisville, Kentucky, United States, 40206|
|Principal Investigator:||John C Meyer, MD||The Eye Care Institute|