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

John C Meyer, MD1 site in 1 country14 target enrollmentOctober 17, 2018

ConditionsMild to Moderate Dry Eye Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild to Moderate Dry Eye Disease
Sponsor: John C Meyer, MD
Enrollment: 14
Locations: 1
Primary Endpoint: Evaluating change in Schirmer score from baseline
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 17, 2018

End Date

November 28, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

John C Meyer, MD

Responsible Party

Sponsor Investigator

Principal Investigator

John C Meyer, MD

Ophthalmologist

The Eye Care Institute

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
•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

Outcomes

Primary Outcomes

Evaluating change in Schirmer score from baseline

Time Frame: 42 days after screening visit

Maximum length of tears absorbed on test strips recorded.

Secondary Outcomes

Evaluating Tear break-up time (TBUT) from baseline.(42 days after screening visit)
Evaluating change in corneal staining score from baseline.(42 days after screening visit)
Evaluating change in Ocular Surface Disease index (OSDI) score from baseline(42 days after screening visit)
Evaluating tear meniscus height from baseline.(42 days after screening visit.)