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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uzma Muzammil, MBBS | Contact | 717-531-0003 | 287070 | umuzammil@pennstatehealth.psu.edu |
| Tealia Wiesman | Contact | 717-531-0003 | 287070 | twiesman@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Murtaza Akhter, MD | Milton S. Hershey Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D065306 | Corneal Injuries |
| ID | Term |
|---|---|
| D005131 | Eye Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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|
| 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 |
|
| 24 Hour |
| 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 |
| D009422 |
| Nervous System Diseases |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |