Trial Outcomes & Findings for Bandage Contact Lens Application for the Management of Corneal Abrasion (NCT NCT04159714)
NCT ID: NCT04159714
Last Updated: 2023-01-13
Results Overview
Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge
Results posted on
2023-01-13
Participant Flow
Participant milestones
| Measure |
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
|
Usual Care Group
Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bandage Contact Lens Application for the Management of Corneal Abrasion
Baseline characteristics by cohort
| Measure |
Bandage Contact Lens (BCL) Group
n=1 Participants
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
|
Usual Care Group
Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-dischargePopulation: Study terminated due to change in practice decreasing availability of eligible patients. Data was not collected or analyzed.
Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible
Outcome measures
Outcome data not reported
Adverse Events
Bandage Contact Lens (BCL) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place