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

Tissue Tech Inc.1 site in 1 country20 target enrollmentJuly 2015

ConditionsDry Eye Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Eye Disease
Sponsor: Tissue Tech Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: Short-term efficacy in terms of corneal nerve regeneration
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

November 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tissue Tech Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Short-term efficacy in terms of corneal nerve regeneration

Time Frame: Change from Baseline to 1 month

Assessed by corneal topography

Short-term efficacy in terms of ocular surface integrity

Time Frame: Change from Baseline to 1 month

Assessed by in vivo confocal microscopy

Short-term efficacy in terms of corneal sensitivity

Time Frame: Change from Baseline to 1 month

Short-term efficacy in terms of ocular clinical symptoms

Time Frame: Change from Baseline to 1 month

Assessed by SPEED questionnaire, pain score, and dry eye workshop grading

Secondary Outcomes

Long-term efficacy in terms of corneal nerve regeneration(Change from Baseline to 3 month)
Long-term efficacy in terms of ocular surface integrity(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(Change from Baseline to 3 month)