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

February 10, 2026 updated by: Murtaza Akhter, Milton S. Hershey Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
four hours after leaving the emergency department.
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
24 hours after discharge from the emergency department
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
72 hours after discharge from the emergency department

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 hours after discharge from the emergency department
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)
in the first 24 hours after being discharged from the emergency department
Frequency NSAID 24 Hour
Time Frame: 24 Hour
24 Hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Murtaza Akhter, MD, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Abrasions

Clinical Trials on Oasis 72-Hour collagen shield

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings