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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: Restylane Defyne

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restylane Defyne recipient	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.

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

Collaborators and Investigators

• Sponsor: John C Meyer, MD

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Actual): August 26, 2019
• Study Completion (Actual): August 26, 2019

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Dry Eye Disease; Restylane-Defyne
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 0619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes