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Sufficient clinical results obtained to support study endpoints.
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This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 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. |
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| Group 2 | Active Comparator | 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. |
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| Group 3 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXLO Corneal Strengthening Solution and UVA Illumination Device | Combination Product | CXLO Corneal Strengthening Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 6 and 12 months |
| Change From Baseline in Maximum Keratometry (KMax) |
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Inclusion Criteria:
A diagnosis of at least one of the following conditions:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregg J Berdy, MD, FACS | Ophthalmology Associates, St. Louis, MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwartz Laser Eye Center | Scottsdale | Arizona | 85260 | United States | ||
| Goodman Eye Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36173242 | Derived | Epstein RJ, Belin MW, Gravemann D, Littner R, Rubinfeld RS. EpiSmart Crosslinking for Keratoconus: A Phase 2 Study. Cornea. 2023 Jul 1;42(7):858-866. doi: 10.1097/ICO.0000000000003136. Epub 2022 Sep 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2017 | Nov 14, 2021 |
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Visual acuity will be evaluated by an observer who is masked as to the treatment protocol to which study subjects have been assigned.
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.
| Baseline and 6 and 12 months |
| San Francisco |
| California |
| 94115 |
| United States |
| Cornea Consultants of Colorado | Littleton | Colorado | 80120-4508 | United States |
| Woolfson Eye Institute | Atlanta | Georgia | 30328 | United States |
| Chicago Cornea Consultants | Chicago | Illinois | 60035 | United States |
| Chicago Cornea Consultants, Ltd. | Hoffman Estates | Illinois | 60169 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63110 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Cornea Associates of Texas | Dallas | Texas | 75231 | United States |
| 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 |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Diagnosis of Keratoconus | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Keratoconus subjects completing assessment | Posted | Mean | Standard Error | logMAR | Baseline and 6 and 12 months |
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| 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 | Keratoconus subjects completing assessment | Posted | Mean | Standard Error | logMAR | Baseline and 6 and 12 months |
| |||||||||||||||||||||||||||||||||
| 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. | Keratoconus subjects completing assessment | Posted | Mean | Standard Error | Diopters | Baseline and 6 and 12 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 750 | 0 | 750 | 0 | 750 |
| EG001 | 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 | 0 | 745 | 0 | 745 | 0 | 745 |
| EG002 | 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 | 0 | 752 | 1 | 752 | 0 | 752 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment | Subject developed diverticulitis 208 days post-procedure; not related; treated and resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Clinical Development Officer | CXL Ophthalmics, LLC | 339-234-6020 | info@cxlophthalmics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2018 | Nov 14, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 12 months |
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