NCT02764814

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

April 25, 2016

Last Update Submit

November 21, 2016

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (4)

  • Short-term efficacy in terms of corneal nerve regeneration

    Assessed by corneal topography

    Change from Baseline to 1 month

  • Short-term efficacy in terms of ocular surface integrity

    Assessed by in vivo confocal microscopy

    Change from Baseline to 1 month

  • Short-term efficacy in terms of corneal sensitivity

    Change from Baseline to 1 month

  • 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

Secondary Outcomes (4)

  • Long-term efficacy in terms of corneal nerve regeneration

    Change from Baseline to 3 month

  • Long-term efficacy in terms of ocular surface integrity

    Change from Baseline to 3 month

  • Long-term efficacy in terms of corneal sensitivity

    Change from Baseline to 3 month

  • Long-term efficacy in terms of ocular clinical symptoms

    Change from Baseline to 3 month

Study Arms (2)

Treatment

ACTIVE COMPARATOR

subjects receiving cryopreserved amniotic membrane

Other: Cryopreserved amniotic membrane

Control

NO INTERVENTION

no intervention

Interventions

Cryopreserved amniotic membraneOTHER

subjects will receive cryopreserved amniotic membrane

Also known as: ProKera Slim
Treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas John Vision Institute, P.C.

Tinley Park, Illinois, 60477, United States

Location

Related Publications (1)

  • 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.

    PMID: 28894606DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Thomas John, MD

    Thomas John Vision Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 6, 2016

Study Start

July 1, 2015

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)