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Management of Signs and Symptoms Associated With Dry Eye Disease

Primary Purpose

Dry Eye Syndromes

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self retained cryopreserved amniotic membrane
lifitegrast ophthalmic solution
Sponsored by
Tissue Tech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center of Excellence in Eye Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

PROKERA SLIM + Standard of Care

Standard of Care

Outcomes

Primary Outcome Measures

Corneal Fluorescein Staining
corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).

Secondary Outcome Measures

Eye Dryness Score
Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort
Ocular Surface Disease Index (OSDI)
Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability

Full Information

First Posted
July 8, 2019
Last Updated
December 1, 2022
Sponsor
Tissue Tech Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04015219
Brief Title
Management of Signs and Symptoms Associated With Dry Eye Disease
Official Title
A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
enrollment constraints
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tissue Tech Inc.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
PROKERA SLIM + Standard of Care
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
Self retained cryopreserved amniotic membrane
Intervention Description
PROKERA SLIM
Intervention Type
Other
Intervention Name(s)
lifitegrast ophthalmic solution
Other Intervention Name(s)
Xiidra
Intervention Description
Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Primary Outcome Measure Information:
Title
Corneal Fluorescein Staining
Description
corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Eye Dryness Score
Description
Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort
Time Frame
1 month
Title
Ocular Surface Disease Index (OSDI)
Description
Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Center of Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Management of Signs and Symptoms Associated With Dry Eye Disease

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