Clinical trial NCT04022382: A Study to Evaluate the Safety and Effectiveness Assessments of Restylane-Defyne for Punctual Occlusion
Official title: A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane-Defyne for Punctal Occlusion in Participants With Mild to Moderate Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry Eye Disease
Restylane-Defyne
Lead sponsor: The Eye Care Institute
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. Participants will be evaluated over four visits.


Eligibility criteria: Inclusion Criteria:

* 21 to 80 years of age
* Baseline OSDI score of at least 13 with no more than 3 responses of "not applicable"
* In both eyes, a baseline Schirmer test with anesthetic of ≤ 10mm/5 minutes
* 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 changes in treatment within 30 days prior to the study or likely to require changes in treatment during the course of the study (i.e. antihistamines, decongestants, oral, topical or aerosol steroids)
* 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: 30 days
Secondary outcomes:
measure: Evaluating change in OSDI score.
timeFrame: 30 Days
measure: Evaluating change in corneal staining score.
timeFrame: 30 Days
measure: Evaluating change in dye disappearance test.
timeFrame: 30 days
measure: Evaluating change in tear break-up time.
timeFrame: 30 days
measure: Evaluating change in tear meniscus height.
timeFrame: 30 days
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: