Corneal AbrasionPhase 2NCT03206723
Bandage Contact Lenses for Corneal Abrasions
A Phase 2 study testing Bandage contact lens, Eyedrop and Hydrocodone in people with Corneal Abrasion and Eye Trauma, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
Two percent of all patients presenting to the Emergency Departments have complaints involving the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause significant discomfort. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Abrasion, Eye Trauma
- What is being tested?
- Bandage contact lens, Eyedrop and Hydrocodone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Mar 2019
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects between ages 18-65 years who present to the emergency department.
- Traumatic corneal abrasion not associated with contact lens use or communicating or adjacent wounds to the eye.
Who cannot join
- Pregnant women
- Breast-feeding women
- Corneal abrasion associated with the wearing contact lenses
- Evidence of corneal ulcer, glaucoma or other ocular pathology, monocular vision
- Wound healing deficits such as collagen vascular disease or concomitant steroid use
- Use of other ocular medications, dry eyes, blepharitis
- Systemic infections
- Known allergies to medicines used in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Harbor-UCLA Medical Center
Torrance, California, 90502
David Tanen, MD, 210-222-3501, dtanen@emedharbor.edu
Pradeep S Prasad, MD
About this study
Official title: Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions
Two percent of all patients presenting to the Emergency Departments have complaints involving the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause significant discomfort. Current treatment includes a thorough evaluation of the eye followed by patching, empiric antibiotics, cycloplegics and oral pain medicines. This study will be a randomized controlled trial to determine the safety and efficacy of BCLs. It will involve the initial patient evaluation followed by a return visit to the Emergency Department within 36 hours for re-examination. At each visit, the patient will be assessed for the size and location of the abrasion along with their report of pain using a visual analog scale. Data will be recorded on a standard data collection sheet. Telephone contact will be made at 30 days to ensure resolution of abrasion and that no complications ensued.
- Conditions
- Corneal Abrasion, Eye Trauma
- Being tested
- Bandage contact lens, Eyedrop, Hydrocodone
- Keywords
- corneal abrasion, contact lens, eye trauma
- Medical subject headings
- Corneal Injuries, Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bandage contact lensDevice
Bandage contact lenses (BCL) have the advantage of pain reduction, facilitating epithelial healing, and improved surface healing. They have been used in the ophthalmology community to treat post-operative eye pain due to the large corneal abrasion created during Excimer photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), and radial keratotomy (RK) with good success.
Bandage contact lenses have also been used in studies in Europe through ophthalmology clinics to treat traumatic corneal abrasions with excellent results. A British study from 1987, found that large diameter contact lenses can be fitted satisfactorily without the use of special equipment such as keratometry. Studies in rabbits have also been performed showing improved rates of healing when using bandage contact lenses. BCLs have been used to treat epithelial defects from various causes for up to 7 months at a time.
EyedropDrug
Fluoroquinolone eyedrops 4x/day
HydrocodoneDrug
Hydrocone 1-2 tabs 4x/day if needed
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 1. Standard care Receives: Drug: Eyedrop; Drug: Hydrocodone |
| Group 2 | Active comparator | 1. Standard care
2. Bandage contact lens Receives: Device: Bandage contact lens; Drug: Eyedrop; Drug: Hydrocodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
The pain difference using Visual Analogue Scale
Measured: 24 hours post treatment
Secondary outcomes (2)
Corneal defect size
Reduction in size (mm) of the defect
Measured: 24 hours post treatment
Pain medication needed
The amount of pain medication needed
Measured: 24 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal AbrasionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Tanen, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206723
- Sponsor's protocol ID
- 30610-01
- Status last verified
- Jan 2018
- First submitted
- 29 Jun 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions
- ClinicalTrials.gov ID
- NCT03206723
- Acronym / sponsor ID
- 30610-01
- Conditions
- Corneal Abrasion, Eye Trauma
- Keywords
- corneal abrasion, contact lens, eye trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 2 Jul 2017 (actual)
- 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.
Two percent of all patients presenting to the Emergency Departments have complaints involving the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause significant discomfort. Current treatment includes a thorough evaluation of the eye followed by patching, empiric antibiotics, cycloplegics and oral pain medicines. This study will be a randomized controlled trial to determine the safety and efficacy of BCLs. It will involve the initial patient evaluation followed by a return visit to the Emergency Department within 36 hours for re-examination. At each visit, the patient will be assessed for the size and location of the abrasion along with their report of pain using a visual analog scale. Data will be recorded on a standard data collection sheet. Telephone contact will be made at 30 days to ensure resolution of abrasion and that no complications ensued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Eyedrop, Drug: Hydrocodone1. Standard care |
| Group 2 | Active comparator | Device: Bandage contact lens, Drug: Eyedrop, Drug: Hydrocodone1. Standard care 2. Bandage contact lens |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects between ages 18-65 years who present to the emergency department.
- Traumatic corneal abrasion not associated with contact lens use or communicating or adjacent wounds to the eye.
Key exclusion criteria (8 listed)
- Pregnant women
- Breast-feeding women
- Corneal abrasion associated with the wearing contact lenses
- Evidence of corneal ulcer, glaucoma or other ocular pathology, monocular vision
- Wound healing deficits such as collagen vascular disease or concomitant steroid use
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 |
|---|---|---|
| Bandage contact lensBandage contact lenses (BCL) have the advantage of pain reduction, facilitating epithelial healing, and improved surface healing. They have been used in the ophthalmology community to treat post-operative eye pain due to the large corneal abrasion created during Excimer photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), and radial keratotomy (RK) with good success. Bandage contact lenses have also been used in studies in Europe through ophthalmology clinics to treat traumatic corneal abrasions with excellent results. A British study from 1987, found that large diameter contact lenses can be fitted satisfactorily without the use of special equipment such as keratometry. Studies in rabbits have also been performed showing improved rates of healing when using bandage contact lenses. BCLs have been used to treat epithelial defects from various causes for up to 7 months at a time. | Device | Group 2 |
| EyedropFluoroquinolone eyedrops 4x/day | Drug | Group 1, Group 2 |
| HydrocodoneHydrocone 1-2 tabs 4x/day if needed | Drug | Group 1, Group 2 |
Primary outcome
Pain scale
Time frame: 24 hours post treatment
The pain difference using Visual Analogue Scale
2 secondary outcomes
Corneal defect size
Time frame: 24 hours post treatment
Pain medication needed
Time frame: 24 hours post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No. IPD will not be shared.
Related trials for Corneal Abrasion
Not yet recruiting
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bandage contact lens, Eyedrop and Hydrocodone in people with Corneal Abrasion and Eye Trauma, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA 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?
The sponsor lists 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Tanen, MD (3102223501, dtanen@labiomed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (time frame: 24 hours post treatment). 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 1 Feb 2018.