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A Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03709641
Recruitment Status : Completed
First Posted : October 17, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
John C Meyer, MD, The Eye Care Institute

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.

Condition or disease Intervention/treatment Phase
Mild to Moderate Dry Eye Disease Device: Restylane Defyne Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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
Actual Study Start Date : October 17, 2018
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Restylane Defyne receiver
Participants will receive Restyane Defyne injected into punctum of one eye.
Device: Restylane Defyne
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 Measures :
  1. Evaluating change in Schirmer score from baseline [ Time Frame: 42 days after screening visit ]
    Maximum length of tears absorbed on test strips recorded.


Secondary Outcome Measures :
  1. Evaluating change in Ocular Surface Disease index (OSDI) score from baseline [ Time Frame: 42 days after screening visit ]
    Participants answer 12 question questionnaire. Scores from section I,II, and III

  2. Evaluating change in corneal staining score from baseline. [ Time Frame: 42 days after screening visit ]
    1.0mg sodium fluorescein strips on lower eye lids for one minute. 5 corneal regions graded using cobalt filter to maximized view of fluorescence.

  3. Evaluating Tear break-up time (TBUT) from baseline. [ Time Frame: 42 days after screening visit ]
    Performed by Keratograph 5M per manufacturer's directions.

  4. Evaluating tear meniscus height from baseline. [ Time Frame: 42 days after screening visit. ]
    Performed by Keratograph 5M per manufacturer's directions.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709641


Locations
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United States, Kentucky
The Eye Care Institute
Louisville, Kentucky, United States, 40206
Sponsors and Collaborators
John C Meyer, MD
Investigators
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Principal Investigator: John C Meyer, MD The Eye Care Institute
  Study Documents (Full-Text)

Documents provided by John C Meyer, MD, The Eye Care Institute:
Study Protocol  [PDF] July 9, 2018


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Responsible Party: John C Meyer, MD, Ophthalmologist, The Eye Care Institute
ClinicalTrials.gov Identifier: NCT03709641     History of Changes
Other Study ID Numbers: 0918
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by John C Meyer, MD, The Eye Care Institute:
Dry Eye Disease
Restyalne Defyne

Additional relevant MeSH terms:
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Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Conjunctivitis
Keratitis
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents