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

Completed · Not applicable

Conditions studied: Dry Eye Disease

In brief

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

Key facts

Study ID

NCT02764814

Run by

BioTissue Holdings, Inc

People needed

20

Starts

2015-07-01

Expected to finish

2016-11-01

Last updated by the study team

2016-11-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.