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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Dry Eye Disease
• Intervention / Treatment: Device: Restylane Defyne

• Study Type: Interventional
• Enrollment (Actual): 14
• 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:

• Twenty-one (21) to 80 years of age
• Baseline Ocular Surface Disease Index score of at least 13 with no more than 3 responses of "not applicable" for each eye individually
• In the study eye, a baseline Schirmer test with anesthetic of ≤ 10 mm/5 minute
• 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 treatment (i.e. antihistamines, decongestants, oral or aerosol steroids).
• Use of steroids, including administration by systemic, inhaled or topical ocular routes (dermatologic steroids not applied to the eyelids are allowed).
• 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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	42 days after screening visit

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: John C Meyer, MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2018
• Primary Completion (ACTUAL): November 28, 2018
• Study Completion (ACTUAL): November 28, 2018

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (ACTUAL): October 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Dry Eye Disease; Restyalne Defyne
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 0918

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