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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764814
• Other study ID #: P014-03
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: November 21, 2016
• Start date: July 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2016
• Source: Tissue Tech Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Other:
• Cryopreserved amniotic membrane
subjects will receive cryopreserved amniotic membrane

Locations

Country	Name	City	State
United States	Thomas John Vision Institute, P.C.	Tinley Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Tissue Tech Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term efficacy in terms of corneal nerve regeneration	Assessed by corneal topography	Change from Baseline to 1 month	No
Primary	Short-term efficacy in terms of ocular surface integrity	Assessed by in vivo confocal microscopy	Change from Baseline to 1 month	No
Primary	Short-term efficacy in terms of corneal sensitivity		Change from Baseline to 1 month	No
Primary	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	No
Secondary	Long-term efficacy in terms of corneal nerve regeneration	Assessed by corneal topography	Change from Baseline to 3 month	No
Secondary	Long-term efficacy in terms of ocular surface integrity	Assessed by in vivo confocal microscopy	Change from Baseline to 3 month	No
Secondary	Long-term efficacy in terms of corneal sensitivity		Change from Baseline to 3 month	No
Secondary	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	No