IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING

NCT ID: NCT07225699

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2028-01-15

Brief 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. One eye from each patient will be considered the study eye.

Conditions

Corneal Abrasions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group (Oasis 72-Hour Collagen Shield)

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.

Group Type: EXPERIMENTAL

Oasis 72-Hour collagen shield

Intervention Type: DEVICE

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.

Control Group ( Sham Collagen Shield )

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.

Group Type: ACTIVE_COMPARATOR

sham collagen shield

Intervention Type: DEVICE

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

Interventions

Oasis 72-Hour collagen shield

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.

Intervention Type: DEVICE

sham collagen shield

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Each of the following criteria must be met for study participation:

1. Male or female, age 18 or older at the time of study enrollment.

2. Corneal abrasion in one eye.

3. Willingness to sign the IRB-approved informed consent form (ICF) for study participation.

4. Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.

Exclusion Criteria

Patient candidates presenting any of the following characteristics will not be eligible for study participation:

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1. Corneal abrasion in both eyes.

2. Allergy to moxifloxacin or other fluoroquinolone antibiotics.

3. Allergy to ibuprofen or other non-steroidal anti-inflammatory drugs.

4. History of neurotrophic cornea for any reason, in the study eye.

5. History of medical conditions known to cause decreased corneal sensation in the study eye including but not limited to HSV, HZO, and diabetes.

6. History of extraocular surgical procedures known to cause decreased corneal sensation in the study eye, including but not limited to trigeminal nerve clamp.

7. Any anterior segment pathology in the study eye that could significantly affect corneal wound healing (e.g. aniridia, clinically significant corneal dystrophies [ABMD], etc.)

8. 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.

9. 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.).

10. History of uveitis in either eye.

11. History of intraocular or corneal surgery in the study eye besides laser peripheral iridotomy (LPI), retinal barrier laser.

12. Current ocular infection in the study eye.

13. Presence of uncontrolled systemic disease that could limit capacity to sign consent or comply with treatment schedule (e.g. mental illness, dementia, etc.).

14. Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Murtaza Akhter

Physician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murtaza Akhter, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Central Contacts

Uzma Muzammil, MBBS

Role: CONTACT

Phone: 717-531-0003

Email: umuzammil@pennstatehealth.psu.edu

Tealia Wiesman

Role: CONTACT

Phone: 717-531-0003

Email: twiesman@pennstatehealth.psu.edu

Other Identifiers

TEMP 1

Identifier Type: -

Identifier Source: org_study_id