NCT04015219

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 23, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

2.2 years

First QC Date

July 8, 2019

Results QC Date

October 18, 2022

Last Update Submit

December 1, 2022

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Eye Dryness Score

    1 month

  • Ocular Surface Disease Index (OSDI)

    1 month

Study Arms (2)

Treatment Arm

EXPERIMENTAL

PROKERA SLIM + Standard of Care

Device: Self retained cryopreserved amniotic membraneOther: lifitegrast ophthalmic solution

Control Arm

ACTIVE COMPARATOR

Standard of Care

Other: lifitegrast ophthalmic solution

Interventions

Self retained cryopreserved amniotic membraneDEVICE

PROKERA SLIM

Treatment Arm
lifitegrast ophthalmic solutionOTHER

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

Also known as: Xiidra
Control ArmTreatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Excellence in Eye Care

Miami, Florida, 33176, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Medical Affairs
Organization
BioTissue
medicalaffairs@biotissue.com
8882968858

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 10, 2019

Study Start

July 18, 2018

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

December 23, 2022

Results First Posted

December 23, 2022

Record last verified: 2022-12

Locations

US(1)