In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye

Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional treatment in patients with moderate to severe Dry Eye Disease (DED)

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Other: Cryopreserved amniotic membrane

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Tinley Park, Illinois, United States, 60477
      • Thomas John Vision Institute, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with moderate to severe DED (Grade 2-4 DEWS)
• Age range: 21 years and older.
• Both genders and all ethnic groups comparable with the local community.
• Subjects able to understand and willing to sign a written informed consent.
• Subjects able and willing to cooperate with investigational plan.
• Subjects able and willing to complete postoperative follow-up.

Exclusion Criteria:

• Symblepharon or lid abnormality preventing ProKera placement.
• Ocular infection within 14 days prior to study entry.
• Active ocular allergies.
• Previous ocular surgery or injury within 3 months before enrollment.
• Previous brain surgery, or Trigeminal nerve damage.
• Other conditions that may affect corneal nerves such as diabetes, thyroid disorders.
• Contact lens wearers.
• Pregnancy or subject expecting to be pregnant.
• Inability or unwillingness of subject to give written informed consent.
• Subjects with known intolerance to PK.
• Subjects use concomitant therapy that affects tear functions or ocular surface integrity.
• Subjects currently engaged in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; no intervention
Active Comparator: Treatment; subjects receiving cryopreserved amniotic membrane	Other: Cryopreserved amniotic membrane; subjects will receive cryopreserved amniotic membrane; Other Names: ProKera Slim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term efficacy in terms of corneal nerve regeneration	Assessed by corneal topography	Change from Baseline to 1 month
Short-term efficacy in terms of ocular surface integrity	Assessed by in vivo confocal microscopy	Change from Baseline to 1 month
Short-term efficacy in terms of corneal sensitivity		Change from Baseline to 1 month
Short-term efficacy in terms of ocular clinical symptoms	Assessed by SPEED questionnaire, pain score, and dry eye workshop grading	Change from Baseline to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term efficacy in terms of corneal nerve regeneration	Assessed by corneal topography	Change from Baseline to 3 month
Long-term efficacy in terms of ocular surface integrity	Assessed by in vivo confocal microscopy	Change from Baseline to 3 month
Long-term efficacy in terms of corneal sensitivity		Change from Baseline to 3 month
Long-term efficacy in terms of ocular clinical symptoms	Assessed by SPEED questionnaire, pain score, and dry eye workshop grading	Change from Baseline to 3 month

Collaborators and Investigators

• Sponsor: Tissue Tech Inc.
• Investigators: Principal Investigator: Thomas John, MD, Thomas John Vision Institute

Publications and helpful links

General Publications

• John T, Tighe S, Sheha H, Hamrah P, Salem ZM, Cheng AMS, Wang MX, Rock ND. Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease. J Ophthalmol. 2017;2017:6404918. doi: 10.1155/2017/6404918. Epub 2017 Aug 15.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: August 1, 2016

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
• Other Study ID Numbers: P014-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No