Trial Outcomes & Findings for Cross Linking for Treatment of Corneal Infection (NCT NCT00912509)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2017-11-22

Participant milestones
Measure	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%	45 Minute Light Duration 45 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Overall Study STARTED	20	10
Overall Study COMPLETED	15	7
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal
Measure	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%	45 Minute Light Duration 45 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Overall Study Lost to Follow-up	1	0
Overall Study Lack of Efficacy	4	3

Cross Linking for Treatment of Corneal Infection

Baseline characteristics by cohort
Measure	30 Minute Light Duration n=20 Participants 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%	45 Minute Light Duration n=10 Participants 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%	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants

Timeframe: 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

Outcome measures
Measure	30 Minute Light Duration n=15 Participants 30 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%	45 Minute Light Duration n=7 Participants 45 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Time to Re-epithelialization	14 Days Interval 6.0 to 28.0	11 Days Interval 6.0 to 29.0

Timeframe: 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

Outcome measures
Measure	30 Minute Light Duration n=15 Participants 30 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%	45 Minute Light Duration n=7 Participants 45 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Time to Resolution of Stromal Infiltration	21 days Interval 8.0 to 33.0	10 days Interval 7.0 to 11.0

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	30 Minute Light Duration n=20 participants at risk 30 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%	45 Minute Light Duration n=10 participants at risk 45 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
Eye disorders Cornea transplant	20.0% 4/20 • Number of events 4	20.0% 2/10 • Number of events 2
Eye disorders Intracorneal injection of voriconazole	5.0% 1/20 • Number of events 1	10.0% 1/10 • Number of events 1
Eye disorders Dendritic lesions characteristic of prior herpes simplex	0.00% 0/20	10.0% 1/10 • Number of events 1

Cornea Research Foundation of America

Phone: 317-814-2990