Management of Signs and Symptoms Associated With Dry Eye Disease

A Prospective, Randomized, and Controlled Clinical Study to Evaluate PROKERA® in the Management of Signs and Symptoms Associated With Dry Eye Disease

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Self retained cryopreserved amniotic membrane; Other: lifitegrast ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Center of Excellence in Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Xiidra
Active Comparator: Control Arm; Standard of Care	Other: lifitegrast ophthalmic solution; Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA); Other Names: Xiidra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye Dryness Score	Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort	1 month
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	1 month

Collaborators and Investigators

• Sponsor: Tissue Tech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): October 5, 2020
• Study Completion (Actual): October 5, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions; Lifitegrast
• Other Study ID Numbers: PROKERA-CS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes