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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.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Self retained cryopreserved amniotic membrane Other: lifitegrast ophthalmic solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease
Actual Study Start Date : July 18, 2018
Actual Primary Completion Date : October 5, 2020
Actual Study Completion Date : October 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases
Drug Information available for: Lifitegrast

Arm Intervention/treatment
Experimental: Treatment Arm
PROKERA SLIM + Standard of Care
Device: Self retained cryopreserved amniotic membrane
PROKERA SLIM

Other: lifitegrast ophthalmic solution
Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Other Name: Xiidra

Active Comparator: Control Arm
Standard of Care
Other: lifitegrast ophthalmic solution
Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Other Name: Xiidra




Primary Outcome Measures :
  1. corneal fluorescein staining [ Time Frame: 1 month ]
    corneal fluorescein staining score of study eye graded from 0 to 9, 9 being worse score


Secondary Outcome Measures :
  1. Eye Dryness Score [ Time Frame: 1 month ]
    Patient subjectively evaluates eye dryness score (0 to 100 maximal discomfort)

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04015219


Locations
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United States, Florida
Center of Excellence in Eye Care
Miami, Florida, United States, 33176
Sponsors and Collaborators
Tissue Tech Inc.
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Responsible Party: Tissue Tech Inc.
ClinicalTrials.gov Identifier: NCT04015219    
Other Study ID Numbers: PROKERA-CS001
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lifitegrast
Pharmaceutical Solutions