Clinical trial NCT03709641: A Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild to Moderate Dry Eye Disease
Keywords: Dry Eye Disease
Restyalne Defyne
Lead sponsor: The Eye Care Institute
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Evaluating change in Schirmer score from baseline
timeFrame: 42 days after screening visit
Secondary outcomes:
measure: Evaluating change in Ocular Surface Disease index (OSDI) score from baseline
timeFrame: 42 days after screening visit
measure: Evaluating change in corneal staining score from baseline.
timeFrame: 42 days after screening visit
measure: Evaluating Tear break-up time (TBUT) from baseline.
timeFrame: 42 days after screening visit
measure: Evaluating tear meniscus height from baseline.
timeFrame: 42 days after screening visit.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
Study officials:
affiliation: The Eye Care Institute
name: John C Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: