Dry Eye Disease
Conditions
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)
Interventions
subjects will receive cryopreserved amniotic membrane
Sponsors
BioTissue Holdings, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-term efficacy in terms of ocular clinical symptoms | Change from Baseline to 1 month | Assessed by SPEED questionnaire, pain score, and dry eye workshop grading |
| Short-term efficacy in terms of corneal nerve regeneration | Change from Baseline to 1 month | Assessed by corneal topography |
| Short-term efficacy in terms of ocular surface integrity | Change from Baseline to 1 month | Assessed by in vivo confocal microscopy |
| Short-term efficacy in terms of corneal sensitivity | Change from Baseline to 1 month | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term efficacy in terms of corneal nerve regeneration | Change from Baseline to 3 month | Assessed by corneal topography |
| Long-term efficacy in terms of ocular surface integrity | Change from Baseline to 3 month | Assessed by in vivo confocal microscopy |
| 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 | Assessed by SPEED questionnaire, pain score, and dry eye workshop grading |
Countries
United States
Outcome results
None listed