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Management of Signs and Symptoms Associated With Dry Eye Disease

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: NCT04015219
Recruitment Status : Terminated (enrollment constraints)
First Posted : July 10, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Tissue Tech Inc.

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE July 18, 2018
Actual Primary Completion Date October 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
corneal fluorescein staining [ Time Frame: 1 month ]
corneal fluorescein staining score of study eye graded from 0 to 9, 9 being worse score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Eye Dryness Score [ Time Frame: 1 month ]
    Patient subjectively evaluates eye dryness score (0 to 100 maximal discomfort)
  • Ocular Surface Disease Index (OSDI) [ Time Frame: 1 month ]
    Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Signs and Symptoms Associated With Dry Eye Disease
Official Title  ICMJE A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease
Brief Summary A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • Device: Self retained cryopreserved amniotic membrane
    PROKERA SLIM
  • Other: lifitegrast ophthalmic solution
    Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
    Other Name: Xiidra
Study Arms  ICMJE
  • Experimental: Treatment Arm
    PROKERA SLIM + Standard of Care
    Interventions:
    • Device: Self retained cryopreserved amniotic membrane
    • Other: lifitegrast ophthalmic solution
  • Active Comparator: Control Arm
    Standard of Care
    Intervention: Other: lifitegrast ophthalmic solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 5, 2020)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2019)
50
Actual Study Completion Date  ICMJE October 5, 2020
Actual Primary Completion Date October 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with moderate dry eye defined as corneal fluorescein staining score of ≥ 3
  • Age ≥ 18 years
  • Distance best corrected visual acuity better than 20/60 Snellen equivalent in each eye
  • Willing to sign a written informed consent to participate
  • Able to follow study instructions, with the intention of completing all required visits

Exclusion Criteria:

  • Presence of persistent corneal epithelial defect or ulcer in either eye
  • Presence of active ocular infection in either eye
  • Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis
  • Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis
  • Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)
  • Contact lens wear
  • History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
  • Presence of cicatricial ocular surface diseases
  • A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
  • Any scheduled or planned ocular or systemic surgery or procedure during the study
  • Pregnancy and women who are expecting to be pregnant.
  • Current enrolment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015219
Other Study ID Numbers  ICMJE PROKERA-CS001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tissue Tech Inc.
Study Sponsor  ICMJE Tissue Tech Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tissue Tech Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP