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

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Other: Cryopreserved amniotic membrane

• Registration Number: NCT02764814
• Lead Sponsor: Tissue Tech Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-06
• Status Verified: 2016-08
• Primary Completion: 2016-09
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Cryopreserved amniotic membrane	subjects receiving cryopreserved amniotic membrane

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thomas John Vision Institute, P.C.; 🇺🇸 Tinley Park, Illinois, United States