Back to resultsA Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion
Primary Purpose
Mild to Moderate Dry Eye Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restylane Defyne
Sponsored by
About this trial
This is an interventional device feasibility trial for Mild to Moderate Dry Eye Disease focused on measuring Dry Eye Disease, Restyalne Defyne
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
Sites / Locations
- The Eye Care Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Restylane Defyne receiver
Arm Description
Participants will receive Restyane Defyne injected into punctum of one eye.
Outcomes
Primary Outcome Measures
Evaluating change in Schirmer score from baseline
Maximum length of tears absorbed on test strips recorded.
Secondary Outcome Measures
Evaluating change in Ocular Surface Disease index (OSDI) score from baseline
Participants answer 12 question questionnaire. Scores from section I,II, and III
Evaluating change in corneal staining score from baseline.
1.0mg sodium fluorescein strips on lower eye lids for one minute. 5 corneal regions graded using cobalt filter to maximized view of fluorescence.
Evaluating Tear break-up time (TBUT) from baseline.
Performed by Keratograph 5M per manufacturer's directions.
Evaluating tear meniscus height from baseline.
Performed by Keratograph 5M per manufacturer's directions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03709641
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John C Meyer, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Dry Eye Disease
Keywords
Dry Eye Disease, Restyalne Defyne
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restylane Defyne receiver
Arm Type
Experimental
Arm Description
Participants will receive Restyane Defyne injected into punctum of one eye.
Intervention Type
Device
Intervention Name(s)
Restylane Defyne
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluating change in Schirmer score from baseline
Description
Maximum length of tears absorbed on test strips recorded.
Time Frame
42 days after screening visit
Secondary Outcome Measure Information:
Title
Evaluating change in Ocular Surface Disease index (OSDI) score from baseline
Description
Participants answer 12 question questionnaire. Scores from section I,II, and III
Time Frame
42 days after screening visit
Title
Evaluating change in corneal staining score from baseline.
Description
1.0mg sodium fluorescein strips on lower eye lids for one minute. 5 corneal regions graded using cobalt filter to maximized view of fluorescence.
Time Frame
42 days after screening visit
Title
Evaluating Tear break-up time (TBUT) from baseline.
Description
Performed by Keratograph 5M per manufacturer's directions.
Time Frame
42 days after screening visit
Title
Evaluating tear meniscus height from baseline.
Description
Performed by Keratograph 5M per manufacturer's directions.
Time Frame
42 days after screening visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Meyer, MD
Organizational Affiliation
The Eye Care Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion
We'll reach out to this number within 24 hrs