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

NCT07225699 | Not Yet Recruiting

• 1 other identifier: STUDY00027794
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Pain Score 4 hours

  \- The primary endpoint will be pain score (10-point Liekert scale) 0=No pain 10=more pain

  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

  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

  72 hours after discharge from the emergency department

Secondary Outcomes (3)

• Dosage NSAID use in first 24 hours

  in the first 24 hours after being discharged from the emergency department

• Frequency NSAID 24 Hour

  24 Hour

• Pain score 24 hours

  24 hours after discharge from the emergency department

Study Arms (2)

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.

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.

Device: sham collagen shield

Interventions

Oasis 72-Hour collagen shield 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.

Treatment group (Oasis 72-Hour Collagen Shield)

sham collagen shield 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

Control Group ( Sham Collagen Shield )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.).

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Corneal Injuries

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Study Officials

• Murtaza Akhter, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uzma Muzammil, MBBS

CONTACT

717-531-0003; umuzammil@pennstatehealth.psu.edu

Tealia Wiesman

CONTACT

717-531-0003; twiesman@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Scientist

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 30, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share