Corneal AbrasionsNCT07225699
IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING
A study testing Oasis 72-Hour collagen shield in people with Corneal Abrasions, run by Milton S. Hershey Medical Center.
Trial summary
This is a single-center, double-arm, patient masked, randomized controlled trial. Subjects will be enrolled in the Emergency Department at the Penn State Milton S. Hershey Medical Center. Eligible subjects must present to the ED and be diagnosed with a traumatic corneal abrasion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Abrasions
- What is being tested?
- Oasis 72-Hour collagen shield
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 30 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Each of the following criteria must be met for study participation:
- Male or female, age 18 or older at the time of study enrollment.
- Corneal abrasion in one eye.
- Willingness to sign the IRB-approved informed consent form (ICF) for study participation.
- Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.
Who cannot join
- Patient candidates presenting any of the following characteristics will not be eligible for study participation:
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- Corneal abrasion in both eyes.
- Allergy to moxifloxacin or other fluoroquinolone antibiotics.
- Allergy to ibuprofen or other non-steroidal anti-inflammatory drugs.
- History of neurotrophic cornea for any reason, in the study eye.
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- History of medical conditions known to cause decreased corneal sensation in the study eye including but not limited to HSV, HZO, and diabetes.
- History of extraocular surgical procedures known to cause decreased corneal sensation in the study eye, including but not limited to trigeminal nerve clamp.
- Any anterior segment pathology in the study eye that could significantly affect corneal wound healing (e.g. aniridia, clinically significant corneal dystrophies [ABMD], etc.)
- Any visually significant intraocular media opacity other than corneal abrasion in the study eye (as determined by the investigator). Such opacities might include corneal scar or vitreous hemorrhage.
- History of any clinically significant retinal pathology or ocular diagnosis in the study eye that could, in the investigator's best judgement, alter or limit visual acuity (e.g. ischemic disease, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, aniridia, epiretinal membrane, etc.).
- History of uveitis in either eye.
- History of intraocular or corneal surgery in the study eye besides laser peripheral iridotomy (LPI), retinal barrier laser.
- Current ocular infection in the study eye.
- Presence of uncontrolled systemic disease that could limit capacity to sign consent or comply with treatment schedule (e.g. mental illness, dementia, etc.).
- Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A SINGLE-CENTER, DOUBLE-ARM, PATIENT MASKED, PROSPECTIVE RANDOMIZED CLINICAL TRIAL TO EVALUATE PATIENT REPORTED OUTCOMES IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING
This is a single-center, double-arm, patient masked, randomized controlled trial. Subjects will be enrolled in the Emergency Department at the Penn State Milton S. Hershey Medical Center. Eligible subjects must present to the ED and be diagnosed with a traumatic corneal abrasion. One eye from each patient will be considered the study eye.
- Conditions
- Corneal Abrasions
- Being tested
- Oasis 72-Hour collagen shield, sham collagen shield
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oasis 72-Hour collagen shieldDevice
All qualified subjects will receive a drop of tetracaine. The treatment group will receive an Oasis 72-Hour collagen shield and instructions to take moxifloxacin 0.5% four times daily as well as ibuprofen 400 mg PO q4 hrs as needed for pain.
sham collagen shieldDevice
The control group will have a sham collagen shield placed (patient will have the impression a lens is placed but it will not actually remain on the eye), and will also be prescribed moxifloxacin 0.5% four times daily and ibuprofen 400 mg PO q4 hrs as needed for pain
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (Oasis 72-Hour Collagen Shield) | Experimental | The treatment group will receive an Oasis 72-Hour collagen shield and instructions to take moxifloxacin 0.5% four times daily as well as ibuprofen 400 mg PO q4 hrs as needed for pain. Receives: Device: Oasis 72-Hour collagen shield |
| Control Group ( Sham Collagen Shield ) | Active comparator | The control group will have a sham collagen shield placed (patient will have the impression a lens is placed but it will not actually remain on the eye), and will also be prescribed moxifloxacin 0.5% four times daily and ibuprofen 400 mg PO q4 hrs as needed for pain. Receives: Device: sham collagen shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score 4 hours
- The primary endpoint will be pain score (10-point Liekert scale) 0=No pain 10=more pain
Measured: four hours after leaving the emergency department.
Pain score 24 hours
The Secondary endpoint will be pain score (10-point Liekert scale) score 0=No pain 10=more pain
Measured: 24 hours after discharge from the emergency department
Pain Score 72 hours
The Secondary endpoint will be pain score (10-point Liekert scale) score 0=No pain 10=more pain
Measured: 72 hours after discharge from the emergency department
Secondary outcomes (3)
Dosage NSAID use in first 24 hours
Dosage of non-steroidal anti-inflammatory drugs (NSAIDs)
Measured: in the first 24 hours after being discharged from the emergency department
Frequency NSAID 24 Hour
Measured: 24 Hour
Pain score 24 hours
The Secondary endpoint will be pain score (10-point Liekert scale) score 0=No pain 10=more pain
Measured: 24 hours after discharge from the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start15 Nov 2026 (estimated)
- Primary completion15 Jan 2029 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal AbrasionsStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murtaza Akhter, Milton S. Hershey Medical Center
- Investigators
- Murtaza Akhter, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225699
- Sponsor's protocol ID
- STUDY00027794
- Status last verified
- Jan 2026
- First submitted
- 5 Nov 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SINGLE-CENTER, DOUBLE-ARM, PATIENT MASKED, PROSPECTIVE RANDOMIZED CLINICAL TRIAL TO EVALUATE PATIENT REPORTED OUTCOMES IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING
- ClinicalTrials.gov ID
- NCT07225699
- Acronym / sponsor ID
- STUDY00027794
- Conditions
- Corneal Abrasions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 10 Nov 2025 (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.
This is a single-center, double-arm, patient masked, randomized controlled trial. Subjects will be enrolled in the Emergency Department at the Penn State Milton S. Hershey Medical Center. Eligible subjects must present to the ED and be diagnosed with a traumatic corneal abrasion. One eye from each patient will be considered the study eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group (Oasis 72-Hour Collagen Shield) | Experimental | Device: Oasis 72-Hour collagen shieldThe treatment group will receive an Oasis 72-Hour collagen shield and instructions to take moxifloxacin 0.5% four times daily as well as ibuprofen 400 mg PO q4 hrs as needed for pain. |
| Control Group ( Sham Collagen Shield ) | Active comparator | Device: sham collagen shieldThe control group will have a sham collagen shield placed (patient will have the impression a lens is placed but it will not actually remain on the eye), and will also be prescribed moxifloxacin 0.5% four times daily and ibuprofen 400 mg PO q4 hrs as needed for pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Each of the following criteria must be met for study participation:
Key exclusion criteria (16 listed)
- Patient candidates presenting any of the following characteristics will not be eligible for study participation:
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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 |
|---|---|---|
| Oasis 72-Hour collagen shieldAll qualified subjects will receive a drop of tetracaine. The treatment group will receive an Oasis 72-Hour collagen shield and instructions to take moxifloxacin 0.5% four times daily as well as ibuprofen 400 mg PO q4 hrs as needed for pain. | Device | Treatment group (Oasis 72-Hour Collagen Shield) |
| sham collagen shieldThe control group will have a sham collagen shield placed (patient will have the impression a lens is placed but it will not actually remain on the eye), and will also be prescribed moxifloxacin 0.5% four times daily and ibuprofen 400 mg PO q4 hrs as needed for pain | Device | Control Group ( Sham Collagen Shield ) |
Primary outcome
Pain Score 4 hours
Time frame: four hours after leaving the emergency department.
- The primary endpoint will be pain score (10-point Liekert scale) 0=No pain 10=more pain
Pain score 24 hours
Time frame: 24 hours after discharge from the emergency department
The Secondary endpoint will be pain score (10-point Liekert scale) score 0=No pain 10=more pain
Pain Score 72 hours
Time frame: 72 hours after discharge from the emergency department
The Secondary endpoint will be pain score (10-point Liekert scale) score 0=No pain 10=more pain
3 secondary outcomes
Dosage NSAID use in first 24 hours
Time frame: in the first 24 hours after being discharged from the emergency department
Frequency NSAID 24 Hour
Time frame: 24 Hour
Pain score 24 hours
Time frame: 24 hours after discharge from the emergency department
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- 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.
Murtaza Akhter, MD principal investigator
Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Oasis 72-Hour collagen shield in people with Corneal Abrasions, run by Milton S. Hershey Medical Center.
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 5 inclusion and 16 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uzma Muzammil, MBBS (717-531-0003 ext. 287070, umuzammil@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score 4 hours (time frame: four hours after leaving the emergency department.). The study lists 3 primary outcomes in all. 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 Jul 2026.