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NCT Number: NCT07225699

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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
  2. 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

  3. 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

Secondary outcomes

  1. Dosage NSAID use in first 24 hours

    Time frame: in the first 24 hours after being discharged from the emergency department

    Dosage of non-steroidal anti-inflammatory drugs (NSAIDs)

  2. Frequency NSAID 24 Hour

    Time frame: 24 Hour

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tealia Wiesman

CONTACT

[email protected]

717-531-0003 ext. 287070

Uzma Muzammil, MBBS

CONTACT

[email protected]

717-531-0003 ext. 287070

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 10, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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