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Change in practice decreasing availability of eligible patients.
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The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bandage Contact Lens (BCL) group | Experimental | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye |
|
| Usual Care Group | No Intervention | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air Optix contact lens | Device | Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Score | Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible | Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hyde | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bandage Contact Lens (BCL) Group | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye Air Optix contact lens: Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage |
| FG001 | Usual Care Group | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study terminated due to change in practice decreasing availability of eligible patients. No participants were enrolled in the Usual Care Group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bandage Contact Lens (BCL) Group | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye Air Optix contact lens: Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Score | Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible | Study terminated due to change in practice decreasing availability of eligible patients. Data was not collected or analyzed. | Posted | Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge |
|
Adverse events were collected from baseline to end of study for a total of approximately 7 days on all participants.
Study terminated due to change in practice decreasing availability of eligible patients. No participants were enrolled in the Usual Care Group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bandage Contact Lens (BCL) Group | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye Air Optix contact lens: Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage |
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Study terminated due to change in practice decreasing availability of eligible patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Hyde | Mayo Clinic | 507-255-4137 | Hyde.Robert1@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2019 | Dec 19, 2022 | Prot_001.pdf |
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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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| Usual Care Group |
Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department |
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Usual Care Group | Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009422 |
| Nervous System Diseases |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |