Overview

This trial has been completed.

Condition dry eye disease
Treatment cryopreserved amniotic membrane
Sponsor Tissue Tech Inc.
Start date July 2015
End date September 2016
Trial size 20 participants
Trial identifier NCT02764814, P014-03

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
subjects receiving cryopreserved amniotic membrane
cryopreserved amniotic membrane ProKera Slim
subjects will receive cryopreserved amniotic membrane
(No Intervention)
no intervention

Primary Outcomes

Measure
Short-term efficacy in terms of corneal nerve regeneration
time frame: Change from Baseline to 1 month
Short-term efficacy in terms of ocular surface integrity
time frame: Change from Baseline to 1 month
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

Secondary Outcomes

Measure
Long-term efficacy in terms of corneal nerve regeneration
time frame: Change from Baseline to 3 month
Long-term efficacy in terms of ocular surface integrity
time frame: Change from Baseline to 3 month
Long-term efficacy in terms of corneal sensitivity
time frame: Change from Baseline to 3 month
Long-term efficacy in terms of ocular clinical symptoms
time frame: Change from Baseline to 3 month

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye
Principal investigator Thomas John, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Tissue Tech Inc..