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OpenTrials
Completed

NCT Number: NCT02764814

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)

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas John Vision Institute, P.C.

Tinley Park, Illinois, 60477, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryopreserved amniotic membrane

Other

subjects will receive cryopreserved amniotic membrane

Other names: ProKera Slim

Primary outcomes

  1. Short-term efficacy in terms of corneal nerve regeneration

    Time frame: Change from Baseline to 1 month

    Assessed by corneal topography

  2. Short-term efficacy in terms of ocular surface integrity

    Time frame: Change from Baseline to 1 month

    Assessed by in vivo confocal microscopy

  3. Short-term efficacy in terms of corneal sensitivity

    Time frame: Change from Baseline to 1 month

  4. 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

  1. Long-term efficacy in terms of corneal nerve regeneration

    Time frame: Change from Baseline to 3 month

    Assessed by corneal topography

  2. Long-term efficacy in terms of ocular surface integrity

    Time frame: Change from Baseline to 3 month

    Assessed by in vivo confocal microscopy

  3. Long-term efficacy in terms of corneal sensitivity

    Time frame: Change from Baseline to 3 month

  4. Long-term efficacy in terms of ocular clinical symptoms

    Time frame: Change from Baseline to 3 month

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

Sponsors and collaborators

Lead sponsor

BioTissue Holdings, Inc

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2016
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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