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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Corneal Abrasions
• Intervention / Treatment: Device: Oasis 72-Hour collagen shield; Device: sham collagen shield

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uzma Muzammil, MBBS; Phone Number: 287070 717-531-0003; Email: umuzammil@pennstatehealth.psu.edu
• Study Contact Backup: Name: Tealia Wiesman; Phone Number: 287070 717-531-0003; Email: twiesman@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

  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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Dosage NSAID use in first 24 hours	Dosage of non-steroidal anti-inflammatory drugs (NSAIDs)	in the first 24 hours after being discharged from the emergency department
Frequency NSAID 24 Hour		24 Hour

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Murtaza Akhter, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 30, 2029

Study Registration Dates

• First Submitted: November 5, 2025
• First Submitted That Met QC Criteria: November 5, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Eye Diseases; Corneal Diseases; Craniocerebral Trauma; Trauma, Nervous System; Eye Injuries; Facial Injuries; Corneal Injuries
• Other Study ID Numbers: STUDY00027794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No