Clinical trial NCT02764814: In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye
Official title: In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: BioTissue Holdings, Inc
Sponsor class: INDUSTRY
First posted: 2016-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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)


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.
* Subjects use concomitant therapy that affects tear functions or ocular surface integrity.
* Subjects currently engaged in another clinical trial.

Primary outcomes:
measure: Short-term efficacy in terms of corneal nerve regeneration
timeFrame: Change from Baseline to 1 month
measure: Short-term efficacy in terms of ocular surface integrity
timeFrame: Change from Baseline to 1 month
measure: Short-term efficacy in terms of corneal sensitivity
timeFrame: Change from Baseline to 1 month
measure: Short-term efficacy in terms of ocular clinical symptoms
timeFrame: Change from Baseline to 1 month
Secondary outcomes:
measure: Long-term efficacy in terms of corneal nerve regeneration
timeFrame: Change from Baseline to 3 month
measure: Long-term efficacy in terms of ocular surface integrity
timeFrame: Change from Baseline to 3 month
measure: Long-term efficacy in terms of corneal sensitivity
timeFrame: Change from Baseline to 3 month
measure: Long-term efficacy in terms of ocular clinical symptoms
timeFrame: Change from Baseline to 3 month
Other outcomes:
Locations:
city: Tinley Park
country: United States
facility: Thomas John Vision Institute, P.C.
state: Illinois
Study officials:
affiliation: Thomas John Vision Institute
name: Thomas John, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: John T, Tighe S, Sheha H, Hamrah P, Salem ZM, Cheng AMS, Wang MX, Rock ND. Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease. J Ophthalmol. 2017;2017:6404918. doi: 10.1155/2017/6404918. Epub 2017 Aug 15.