Trial Outcomes & Findings for Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas (NCT NCT03029104)
NCT ID: NCT03029104
Last Updated: 2022-01-12
Results Overview
Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2228 participants
Primary outcome timeframe
Baseline and 6 and 12 months
Results posted on
2022-01-12
Participant Flow
Participant milestones
| Measure |
Group 1
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 2
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 3
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
745
|
735
|
748
|
|
Overall Study
COMPLETED
|
612
|
597
|
623
|
|
Overall Study
NOT COMPLETED
|
133
|
138
|
125
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Baseline characteristics by cohort
| Measure |
Group 1
n=745 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 2
n=735 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 3
n=748 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Total
n=2228 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 13.11 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 13.03 • n=4 Participants
|
|
Age, Customized
≤21 years
|
175 participants
n=5 Participants
|
163 participants
n=7 Participants
|
175 participants
n=5 Participants
|
513 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
221 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
658 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
524 Participants
n=5 Participants
|
518 Participants
n=7 Participants
|
528 Participants
n=5 Participants
|
1570 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
142 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
398 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
603 Participants
n=5 Participants
|
617 Participants
n=7 Participants
|
609 Participants
n=5 Participants
|
1829 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
92 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
280 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
582 Participants
n=5 Participants
|
573 Participants
n=7 Participants
|
584 Participants
n=5 Participants
|
1739 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
745 participants
n=5 Participants
|
735 participants
n=7 Participants
|
748 participants
n=5 Participants
|
2228 participants
n=4 Participants
|
|
Diagnosis of Keratoconus
|
644 Participants
n=5 Participants
|
635 Participants
n=7 Participants
|
643 Participants
n=5 Participants
|
1922 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 and 12 monthsPopulation: Keratoconus subjects completing assessment
Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline
Outcome measures
| Measure |
Group 1
n=542 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 2
n=534 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 3
n=529 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
|---|---|---|---|
|
Change From Baseline in Corrected Distance Visual Acuity (CDVA)
6 months
|
-0.058 logMAR
Standard Error 0.0088
|
-0.068 logMAR
Standard Error 0.0094
|
-0.064 logMAR
Standard Error 0.0104
|
|
Change From Baseline in Corrected Distance Visual Acuity (CDVA)
12 months
|
-0.074 logMAR
Standard Error 0.0119
|
-0.060 logMAR
Standard Error 0.0127
|
-0.071 logMAR
Standard Error 0.0176
|
SECONDARY outcome
Timeframe: Baseline and 6 and 12 monthsPopulation: Keratoconus subjects completing assessment
Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline
Outcome measures
| Measure |
Group 1
n=541 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 2
n=533 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 3
n=528 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
|---|---|---|---|
|
Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)
6 months
|
-0.0853 logMAR
Standard Error 0.0150
|
-0.1099 logMAR
Standard Error 0.0150
|
-0.0990 logMAR
Standard Error 0.0155
|
|
Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)
12 months
|
-0.0875 logMAR
Standard Error 0.0191
|
-0.0696 logMAR
Standard Error 0.0197
|
-0.1243 logMAR
Standard Error 0.0212
|
SECONDARY outcome
Timeframe: Baseline and 6 and 12 monthsPopulation: Keratoconus subjects completing assessment
Kmax is the maximum value of corneal curvature in Diopters. Changes in Kmax are reported as the value at 6 and 12 months minus the value at baseline.
Outcome measures
| Measure |
Group 1
n=542 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 2
n=533 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 3
n=527 Participants
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
|---|---|---|---|
|
Change From Baseline in Maximum Keratometry (KMax)
12 months
|
-0.2859 Diopters
Standard Error 0.1204
|
-0.5268 Diopters
Standard Error 0.1716
|
-0.5256 Diopters
Standard Error 0.1707
|
|
Change From Baseline in Maximum Keratometry (KMax)
6 months
|
-0.1979 Diopters
Standard Error 0.1069
|
-0.4033 Diopters
Standard Error 0.1228
|
-0.3673 Diopters
Standard Error 0.1125
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=750 participants at risk
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 2
n=745 participants at risk
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
Group 3
n=752 participants at risk
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
CXLO Corneal Strengthening Solution and UVA Illumination Device: CXLO Corneal Strengthening Solution
|
|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/750 • 12 months
A total of 2,228 subjects were randomized and treated in this study (Treated Analysis Set). 1,583 (71%) of these subjects received bilateral, simultaneous treatments. The Safety Analysis Set (SAS) is larger than the Treated Analysis Set because subjects who had an initial unilateral treatment and then had a subsequent procedure, appear in the SAS under two different treatment groups, if the subsequent treatment differs from the initial treatment. This occurred in 19 subjects.
|
0.00%
0/745 • 12 months
A total of 2,228 subjects were randomized and treated in this study (Treated Analysis Set). 1,583 (71%) of these subjects received bilateral, simultaneous treatments. The Safety Analysis Set (SAS) is larger than the Treated Analysis Set because subjects who had an initial unilateral treatment and then had a subsequent procedure, appear in the SAS under two different treatment groups, if the subsequent treatment differs from the initial treatment. This occurred in 19 subjects.
|
0.13%
1/752 • 12 months
A total of 2,228 subjects were randomized and treated in this study (Treated Analysis Set). 1,583 (71%) of these subjects received bilateral, simultaneous treatments. The Safety Analysis Set (SAS) is larger than the Treated Analysis Set because subjects who had an initial unilateral treatment and then had a subsequent procedure, appear in the SAS under two different treatment groups, if the subsequent treatment differs from the initial treatment. This occurred in 19 subjects.
|
Other adverse events
Adverse event data not reported
Additional Information
Chief Clinical Development Officer
CXL Ophthalmics, LLC
Phone: 339-234-6020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place