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

ConditionCorneal Abrasions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment group (Oasis 72-Hour Collagen Shield)Experimental treatment 1 intervention
Group B: Control Group ( Sham Collagen Shield )Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Score 4 hours

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

Time frame
four hours after leaving the emergency department.
2

Pain score 24 hours

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

Time frame
24 hours after discharge from the emergency department
3

Pain Score 72 hours

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

Time frame
72 hours after discharge from the emergency department

Secondary outcomes

1

Dosage NSAID use in first 24 hours

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

Time frame
in the first 24 hours after being discharged from the emergency department
2

Frequency NSAID 24 Hour

Time frame
24 Hour
3

Pain score 24 hours

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

Time frame
24 hours after discharge from the emergency department

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: