A Study to Evaluate the Safety and Effectiveness Assessments of Restylane-Defyne for Punctual Occlusion

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane-Defyne for Punctal Occlusion in Participants With Mild to Moderate Dry Eye Disease

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Device: Restylane Defyne


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21 to 80 years of age Baseline OSDI score of at least 13 with no more than 3 responses of not applicable In both eyes, a baseline Schirmer test with anesthetic of ≤ 10mm/5 minutes Literate, able to speak English and able to complete the questionnaire independently Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol. Exclusion Criteria: Use of ophthalmic cyclosporine or lifitegrast within 30 days prior to Day 0 History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery Corneal transplant in either eye Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease) The history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer. Active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring changes in treatment within 30 days prior to the study or likely to require changes in treatment during the course of the study (i.e. antihistamines, decongestants, oral, topical or aerosol steroids) Participation in a clinical trial during the past 30 days Women who are pregnant, planning a pregnancy, or nursing at study entry.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane Defyne recipient<br> | Device: Restylane Defyne<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating change in Schirmer score from baseline. | Maximum length of tears absorbed on test strips recorded. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye Disease, Restylane-Defyne