Infectious Keratitis
Conditions
Keywords
infectious keratitis, cross linking, corneal ulcer, corneal infection, collagen cross linking
Brief summary
This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.
Interventions
DRUGriboflavin
riboflavin 0.1% is applied every 2 minutes for 30 minutes
DEVICEUVX Light
UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Sponsors
Cornea Research Foundation of America
Price Vision Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of infectious keratitis
Exclusion criteria
* corneal ulcer that has perforated * corneal ulcer that has produced a descemetocele * women who are pregnant or breastfeeding * patients who are immunocompromised or unwilling or unable to comply with a medication regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Re-epithelialization | Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete |
Secondary
| Measure | Time frame |
|---|---|
| Time to Resolution of Stromal Infiltration | day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 30 Minute Light Duration 30 minute treatment with UVX light
riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% | 20 |
| 45 Minute Light Duration 45 minute treatment with UVX light
riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes
UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 4 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | 30 Minute Light Duration | 45 Minute Light Duration | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 4 Participants | 17 Participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 20 | 4 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 10 |
Outcome results
Primary
Time to Re-epithelialization
Time frame: Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 30 Minute Light Duration | Time to Re-epithelialization | 14 Days |
| 45 Minute Light Duration | Time to Re-epithelialization | 11 Days |
Secondary
Time to Resolution of Stromal Infiltration
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 30 Minute Light Duration | Time to Resolution of Stromal Infiltration | 21 days |
| 45 Minute Light Duration | Time to Resolution of Stromal Infiltration | 10 days |