Dry Eye DiseaseNCT02764814
In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye
A study testing Cryopreserved amniotic membrane in people with Dry Eye Disease, run by BioTissue Holdings, Inc at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Cryopreserved amniotic membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas John Vision Institute, P.C.
Tinley Park, Illinois, 60477
About this study
Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional treatment in patients with moderate to severe Dry Eye Disease (DED)
- Conditions
- Dry Eye Disease
- Being tested
- Cryopreserved amniotic membrane
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved amniotic membraneOther
Also called ProKera Slim
subjects will receive cryopreserved amniotic membrane
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | subjects receiving cryopreserved amniotic membrane Receives: Other: Cryopreserved amniotic membrane |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term efficacy in terms of corneal nerve regeneration
Assessed by corneal topography
Measured: Change from Baseline to 1 month
Short-term efficacy in terms of ocular surface integrity
Assessed by in vivo confocal microscopy
Measured: Change from Baseline to 1 month
Short-term efficacy in terms of corneal sensitivity
Measured: 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
Measured: Change from Baseline to 1 month
Secondary outcomes (4)
Long-term efficacy in terms of corneal nerve regeneration
Assessed by corneal topography
Measured: Change from Baseline to 3 month
Long-term efficacy in terms of ocular surface integrity
Assessed by in vivo confocal microscopy
Measured: Change from Baseline to 3 month
Long-term efficacy in terms of corneal sensitivity
Measured: Change from Baseline to 3 month
Long-term efficacy in terms of ocular clinical symptoms
Assessed by SPEED questionnaire, pain score, and dry eye workshop grading
Measured: Change from Baseline to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas John, MD, Principal investigator, Thomas John Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764814
- Sponsor's protocol ID
- P014-03
- Status last verified
- Aug 2016
- First submitted
- 25 Apr 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28894606
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Confocal Microscopic Analysis of Corneal Nerve Changes After ProKera Slim® for Dry Eye
- ClinicalTrials.gov ID
- NCT02764814
- Acronym / sponsor ID
- P014-03
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective controlled pilot study to compare the outcome of ProKera® (PK) and conventional treatment in patients with moderate to severe Dry Eye Disease (DED)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Other: Cryopreserved amniotic membranesubjects receiving cryopreserved amniotic membrane |
| Control | No intervention | –no intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved amniotic membraneAlso: ProKera Slimsubjects will receive cryopreserved amniotic membrane | Other | Treatment |
Primary outcome
Short-term efficacy in terms of corneal nerve regeneration
Time frame: Change from Baseline to 1 month
Assessed by corneal topography
Short-term efficacy in terms of ocular surface integrity
Time frame: Change from Baseline to 1 month
Assessed by in vivo confocal microscopy
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
Assessed by SPEED questionnaire, pain score, and dry eye workshop grading
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Derived from this study: PubMed 28894606John 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas John, MD principal investigator
Thomas John Vision Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryopreserved amniotic membrane in people with Dry Eye Disease, run by BioTissue Holdings, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term efficacy in terms of corneal nerve regeneration (time frame: Change from Baseline to 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.