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

John C Meyer, MD

Status

Completed

Conditions

Mild to Moderate Dry Eye Disease

Treatments

Device: Restylane Defyne

Study type

Interventional

Funder types

Other

Identifiers

NCT03709641

0918

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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