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

NCT04022382 | Completed FDA Device

• 1 other identifier: 0619
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

Dry Eye Disease; Restylane-Defyne

Outcome Measures

Primary Outcomes (1)

• Evaluating change in Schirmer score from baseline.

  Maximum length of tears absorbed on test strips recorded.

  30 days

Secondary Outcomes (5)

• Evaluating change in OSDI score.

  30 Days

• Evaluating change in corneal staining score.

  30 Days

• Evaluating change in dye disappearance test.

  30 days

• Evaluating change in tear break-up time.

  30 days

• Evaluating change in tear meniscus height.

  30 days

Study Arms (1)

Restylane Defyne recipient

EXPERIMENTAL

Device: Restylane Defyne

Interventions

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.

Restylane Defyne recipient

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• John C Meyer, MD: lead

Study Sites (1)

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• John C Meyer, MD

  The Eye Care Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: July 18, 2019
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)