CorneaNCT02395952
Healing of Persistent Epithelial Defects
A study testing carboxymethylcellulose sodium, Acuvue Oasys Bandage Contact Lens and Ambiodisk in people with Cornea, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the relative efficacy of four different treatment modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane, Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following retina surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cornea
- What is being tested?
- carboxymethylcellulose sodium, Acuvue Oasys Bandage Contact Lens and Ambiodisk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Feb 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
3.1 Inclusion Criteria
- Adults aged 18 and older (inclusive) at the time of study enrollment
- Recent history of retina surgery
- Presence of persistent epithelial defect 7 days or later after surgery
- English speaking
3.2 Exclusion Criteria
- Non-English speaking patients
- Inability to incapacity to provide consent for the study
- History of corneal epithelial or limbal stem cell disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Eye Center
Hershey, Pennsylvania, 17033
About this study
Official title: Comparison of Standard of Care Treatments for Post-operative Non-healing Epithelial Defects
The purpose of this study is to compare the relative efficacy of four different treatment modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane, Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following retina surgery.
- Conditions
- Cornea
- Being tested
- carboxymethylcellulose sodium, Acuvue Oasys Bandage Contact Lens, Ambiodisk, Prokera
- Keywords
- cornea, epithelial defect, amniotic membrane
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboxymethylcellulose sodiumDrug
frequent topical lubrication with artificial tears
Acuvue Oasys Bandage Contact LensDevice
AmbiodiskDevice
ProkeraDevice
| Study group | Role | What they receive |
|---|---|---|
| Lubrication | Active comparator | Not described Receives: Drug: carboxymethylcellulose sodium |
| Bandage Contact Lens | Active comparator | Acuvue Oasys Contact Lens Receives: Device: Acuvue Oasys Bandage Contact Lens |
| Prokera | Active comparator | Wet amniotic membrane mounted on plastic retaining ring Receives: Device: Prokera |
| Ambiodisk | Active comparator | Freeze dried amniotic membrane Receives: Device: Ambiodisk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abscence of persistent epithelial defect
Measured: 22 days
Secondary outcomes (2)
Rate of epithelial healing in mm2/day
Measured: 22 days
Infection
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: No patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth M Pantanelli, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395952
- Sponsor's protocol ID
- STUDY00001309
- Status last verified
- Feb 2019
- First submitted
- 10 Mar 2015
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard of Care Treatments for Post-operative Non-healing Epithelial Defects
- ClinicalTrials.gov ID
- NCT02395952
- Acronym / sponsor ID
- STUDY00001309
- Conditions
- Cornea
- Keywords
- cornea, epithelial defect, amniotic membrane
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 24 Mar 2015 (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.
The purpose of this study is to compare the relative efficacy of four different treatment modalities (i.e. aggressive lubrication, bandage contact lens, Ambiodisk amniotic membrane, Prokera amniotic membrane) in the healing of persistent corneal epithelial defects following retina surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lubrication | Active comparator | Drug: carboxymethylcellulose sodium |
| Bandage Contact Lens | Active comparator | Device: Acuvue Oasys Bandage Contact LensAcuvue Oasys Contact Lens |
| Prokera | Active comparator | Device: ProkeraWet amniotic membrane mounted on plastic retaining ring |
| Ambiodisk | Active comparator | Device: AmbiodiskFreeze dried amniotic membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carboxymethylcellulose sodiumfrequent topical lubrication with artificial tears | Drug | Lubrication |
| Acuvue Oasys Bandage Contact Lens | Device | Bandage Contact Lens |
| Ambiodisk | Device | Ambiodisk |
| Prokera | Device | Prokera |
Primary outcome
Abscence of persistent epithelial defect
Time frame: 22 days
2 secondary outcomes
Rate of epithelial healing in mm2/day
Time frame: 22 days
Infection
Time frame: 22 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carboxymethylcellulose sodium, Acuvue Oasys Bandage Contact Lens and Ambiodisk in people with Cornea, run by Milton S. Hershey Medical Center 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?
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: withdrawn, as of the sponsor's last update on 5 Feb 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Abscence of persistent epithelial defect (time frame: 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2019.