Corneal Diseases, Eye Diseases, Keratoconus, Photosensitizing Agents
Conditions
Keywords
Keratoconus, Forme fruste keratoconus, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, Diurnal fluctuation post-radial keratotomy, Terrien's marginal degeneration
Brief summary
This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.
Detailed description
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, diurnal fluctuation post-radial keratotomy, or Terrien's marginal degeneration. This is an outcomes study, all patients receive treatment.
Interventions
COMBINATION_PRODUCTCXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution
Sponsors
Cxlusa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Visual acuity will be evaluated by an observer who is masked as to the treatment protocol to which study subjects have been assigned.
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of at least one of the following conditions: 1. Keratoconus 2. Forme fruste keratoconus 3. Post-LASIK ectasia 4. Pellucid marginal degeneration 5. Forme fruste pellucid marginal degeneration 6. Diurnal fluctuation post-radial keratotomy 7. Terrien's marginal degeneration
Exclusion criteria
1. Corneal thickness \< 375 microns measured by ultrasound or Pentacam. 2. Contraindications or hypersensitivities to any study medications or their components. 3. Pregnancy or breastfeeding. 4. Any history of herpes simplex corneal disease in an eye to be treated. 5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment. 6. Inability to cooperate with diagnostic tests. 7. Enrollment in another ophthalmic clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Corrected Distance Visual Acuity (CDVA) | Baseline and 6 and 12 months | Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | Baseline and 6 and 12 months | Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline |
| Change From Baseline in Maximum Keratometry (KMax) | Baseline and 6 and 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 745 |
| 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 | 735 |
| 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 | 748 |
| Total | 2,228 |
Baseline characteristics
| Characteristic | Group 3 | Group 2 | Group 1 | Total |
|---|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 12.94 | 32.4 years STANDARD_DEVIATION 13.11 | 32.6 years STANDARD_DEVIATION 13.04 | 32.5 years STANDARD_DEVIATION 13.03 |
| Age, Customized ≤21 years | 175 participants | 163 participants | 175 participants | 513 participants |
| Diagnosis of Keratoconus | 643 Participants | 635 Participants | 644 Participants | 1922 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 138 Participants | 118 Participants | 142 Participants | 398 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 609 Participants | 617 Participants | 603 Participants | 1829 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 31 Participants | 38 Participants | 32 Participants | 101 Participants |
| Race (NIH/OMB) Black or African American | 99 Participants | 89 Participants | 92 Participants | 280 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 7 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants | 26 Participants | 34 Participants | 89 Participants |
| Race (NIH/OMB) White | 584 Participants | 573 Participants | 582 Participants | 1739 Participants |
| Region of Enrollment United States | 748 participants | 735 participants | 745 participants | 2228 participants |
| Sex: Female, Male Female | 220 Participants | 217 Participants | 221 Participants | 658 Participants |
| Sex: Female, Male Male | 528 Participants | 518 Participants | 524 Participants | 1570 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 750 | 0 / 745 | 0 / 752 |
| other Total, other adverse events | 0 / 750 | 0 / 745 | 0 / 752 |
| serious Total, serious adverse events | 0 / 750 | 0 / 745 | 1 / 752 |
Outcome results
Primary
Change From Baseline in Corrected Distance Visual Acuity (CDVA)
Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline
Time frame: Baseline and 6 and 12 months
Population: Keratoconus subjects completing assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Change From Baseline in Corrected Distance Visual Acuity (CDVA) | 6 months | -0.058 logMAR | Standard Error 0.0088 |
| Group 1 | Change From Baseline in Corrected Distance Visual Acuity (CDVA) | 12 months | -0.074 logMAR | Standard Error 0.0119 |
| Group 2 | Change From Baseline in Corrected Distance Visual Acuity (CDVA) | 6 months | -0.068 logMAR | Standard Error 0.0094 |
| Group 2 | Change From Baseline in Corrected Distance Visual Acuity (CDVA) | 12 months | -0.060 logMAR | Standard Error 0.0127 |
| Group 3 | Change From Baseline in Corrected Distance Visual Acuity (CDVA) | 6 months | -0.064 logMAR | Standard Error 0.0104 |
| Group 3 | Change From Baseline in Corrected Distance Visual Acuity (CDVA) | 12 months | -0.071 logMAR | Standard Error 0.0176 |
Secondary
Change From Baseline in Maximum Keratometry (KMax)
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.
Time frame: Baseline and 6 and 12 months
Population: Keratoconus subjects completing assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Change From Baseline in Maximum Keratometry (KMax) | 6 months | -0.1979 Diopters | Standard Error 0.1069 |
| Group 1 | Change From Baseline in Maximum Keratometry (KMax) | 12 months | -0.2859 Diopters | Standard Error 0.1204 |
| Group 2 | Change From Baseline in Maximum Keratometry (KMax) | 6 months | -0.4033 Diopters | Standard Error 0.1228 |
| Group 2 | Change From Baseline in Maximum Keratometry (KMax) | 12 months | -0.5268 Diopters | Standard Error 0.1716 |
| Group 3 | Change From Baseline in Maximum Keratometry (KMax) | 6 months | -0.3673 Diopters | Standard Error 0.1125 |
| Group 3 | Change From Baseline in Maximum Keratometry (KMax) | 12 months | -0.5256 Diopters | Standard Error 0.1707 |
Secondary
Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)
Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline
Time frame: Baseline and 6 and 12 months
Population: Keratoconus subjects completing assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | 6 months | -0.0853 logMAR | Standard Error 0.015 |
| Group 1 | Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | 12 months | -0.0875 logMAR | Standard Error 0.0191 |
| Group 2 | Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | 6 months | -0.1099 logMAR | Standard Error 0.015 |
| Group 2 | Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | 12 months | -0.0696 logMAR | Standard Error 0.0197 |
| Group 3 | Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | 6 months | -0.0990 logMAR | Standard Error 0.0155 |
| Group 3 | Change From Baseline in Uncorrected Distance Visual Acuity (UCVA) | 12 months | -0.1243 logMAR | Standard Error 0.0212 |