Corneal AbrasionNCT04159714
Bandage Contact Lens Application for the Management of Corneal Abrasion
A study testing Air Optix contact lens in people with Corneal Abrasion, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Abrasion
- What is being tested?
- Air Optix contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 24 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Superficial Corneal Abrasion
Who cannot join
- Incarceration
- Pregnancy
- Inability to Provide Informed Consent
- Infectious keratitis
- Retained foreign bodies in the eye
- Active infection involving the orbit or periorbital region
Show all 15Show fewer
- Patients who are not able to or who are deemed unlikely to follow-up with ophthalmology
- A history or recent contact lens wear
- A lack of trauma or an unclear history of trauma as the inciting cause of the abrasion
- Allergy to the antimicrobial solution (POLYTRIM)
- Women who are currently breastfeeding
- Chronic eye drop use
- A history of eye surgery other than cataract surgery (greater than 6 months prior to abrasion)
- Diabetes (Patients with even mild diabetic neuropathy can have decreased pain sensation and also delayed corneal epithelial healing)
- Any eye condition that may be deemed to interfere with the conduct of the protocol or outcome measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bandage Contact Lens Application for the Management of Corneal Abrasion in the Emergency Department
The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.
- Conditions
- Corneal Abrasion
- Being tested
- Air Optix contact lens
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Optix contact lensDevice
Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage
| Study group | Role | What they receive |
|---|---|---|
| Bandage Contact Lens (BCL) group | Experimental | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye Receives: Device: Air Optix contact lens |
| Usual Care Group | No intervention | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible
Measured: Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start10 Sep 2019
- Primary completion24 Oct 2019
- Study completion24 Oct 2019
Why it stopped: Change in practice decreasing availability of eligible patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal AbrasionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert J. Hyde, Mayo Clinic
- Investigators
- Robert Hyde, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159714
- Sponsor's protocol ID
- 18-009586
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2019
- Last updated
- 13 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bandage Contact Lens Application for the Management of Corneal Abrasion in the Emergency Department
- ClinicalTrials.gov ID
- NCT04159714
- Acronym / sponsor ID
- 18-009586
- Conditions
- Corneal Abrasion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in practice decreasing availability of eligible patients.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Posted 13 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bandage Contact Lens (BCL) group | Experimental | Device: Air Optix contact lensSubjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye |
| Usual Care Group | No intervention | –Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Superficial Corneal Abrasion
Key exclusion criteria (15 listed)
- Incarceration
- Pregnancy
- Inability to Provide Informed Consent
- Infectious keratitis
- Retained foreign bodies in the eye
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 |
|---|---|---|
| Air Optix contact lensContact lens will be placed on the surface of the patient's eye and is to be used as a bandage | Device | Bandage Contact Lens (BCL) group |
Primary outcome
Change in Pain Score
Time frame: Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge
Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Robert Hyde principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Optix contact lens in people with Corneal Abrasion, run by Mayo Clinic 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 1 inclusion and 15 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: stopped early, as of the sponsor's last update on 13 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain Score (time frame: Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge). 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 13 Jan 2023.