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

NCT03709641 | Completed FDA Device

• 1 other identifier: 0918
• Study Type: interventional
• Target: 14
• 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 Restyalne Defyne and the other eye injected with saline solution. Participants will be evaluated over four visits.

Conditions

Mild to Moderate Dry Eye Disease

Keywords

Dry Eye Disease; Restyalne Defyne

Outcome Measures

Primary Outcomes (1)

• Evaluating change in Schirmer score from baseline

  Maximum length of tears absorbed on test strips recorded.

  42 days after screening visit

Secondary Outcomes (4)

• Evaluating change in Ocular Surface Disease index (OSDI) score from baseline

  42 days after screening visit

• Evaluating change in corneal staining score from baseline.

  42 days after screening visit

• Evaluating Tear break-up time (TBUT) from baseline.

  42 days after screening visit

• Evaluating tear meniscus height from baseline.

  42 days after screening visit.

Study Arms (1)

Restylane Defyne receiver

EXPERIMENTAL

Participants will receive Restyane Defyne injected into punctum of one eye.

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 receiver

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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

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

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: October 17, 2018
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: December 10, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)