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

NCT ID: NCT03709641

Last Updated: 2018-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2018-11-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Restylane Defyne receiver

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

Group Type: EXPERIMENTAL

Restylane Defyne

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John C Meyer, MD

OTHER

Sponsor Role: lead

Responsible Party

John C Meyer, MD

Ophthalmologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John C Meyer, MD

Role: PRINCIPAL_INVESTIGATOR

The Eye Care Institute

Locations

The Eye Care Institute

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

0918

Identifier Type: -

Identifier Source: org_study_id