Back to resultsA Study to Evaluate the Safety and Effectiveness Assessments of Restylane-Defyne for Punctual Occlusion
Primary Purpose
Dry Eye
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 Dry Eye focused on measuring Dry Eye Disease, Restylane-Defyne
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.
Sites / Locations
- The Eye Care Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Restylane Defyne recipient
Arm Description
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 OSDI score.
Participants answer 12 question questionnaire. Scores from section I,II, and III.
Evaluating change in corneal staining score.
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 change in dye disappearance test.
Evaluating change in tear break-up time.
Performed by Keratograph 5M per manufacturer's directions.
Evaluating change in tear meniscus height.
Performed by Keratograph 5M per manufacturer's directions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04022382
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
August 26, 2019 (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 0.1ml Restylane Defyne and the other eye injected with 0.2ml Restylane Defyne. 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
Dry Eye
Keywords
Dry Eye Disease, Restylane-Defyne
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restylane Defyne recipient
Arm Type
Experimental
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
30 days
Secondary Outcome Measure Information:
Title
Evaluating change in OSDI score.
Description
Participants answer 12 question questionnaire. Scores from section I,II, and III.
Time Frame
30 Days
Title
Evaluating change in corneal staining score.
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
30 Days
Title
Evaluating change in dye disappearance test.
Time Frame
30 days
Title
Evaluating change in tear break-up time.
Description
Performed by Keratograph 5M per manufacturer's directions.
Time Frame
30 days
Title
Evaluating change in tear meniscus height.
Description
Performed by Keratograph 5M per manufacturer's directions.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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 Assessments of Restylane-Defyne for Punctual Occlusion
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