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Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Primary Purpose

Keratoconus, Corneal Diseases, Eye Diseases

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CXLO Corneal Strengthening Solution and UVA Illumination Device
Sponsored by
Cxlusa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Forme fruste keratoconus, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, Diurnal fluctuation post-radial keratotomy, Terrien's marginal degeneration

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Schwartz Laser Eye Center
  • Goodman Eye Center
  • Cornea Consultants of Colorado
  • Woolfson Eye Institute
  • Chicago Cornea Consultants
  • Chicago Cornea Consultants, Ltd.
  • Ophthalmology Associates
  • Cleveland Eye Clinic
  • Cornea Associates of Texas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
January 20, 2017
Last Updated
December 15, 2021
Sponsor
Cxlusa
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1. Study Identification

Unique Protocol Identification Number
NCT03029104
Brief Title
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Official Title
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Sufficient clinical results obtained to support study endpoints.
Study Start Date
December 21, 2016 (Actual)
Primary Completion Date
December 27, 2020 (Actual)
Study Completion Date
December 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cxlusa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Corneal Diseases, Eye Diseases, Photosensitizing Agents
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
2228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
CXLO Corneal Strengthening Solution and UVA Illumination Device
Intervention Description
CXLO Corneal Strengthening Solution
Primary Outcome Measure Information:
Title
Change From Baseline in Corrected Distance Visual Acuity (CDVA)
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)
Description
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
Title
Change From Baseline in Maximum Keratometry (KMax)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of at least one of the following conditions: Keratoconus Forme fruste keratoconus Post-LASIK ectasia Pellucid marginal degeneration Forme fruste pellucid marginal degeneration Diurnal fluctuation post-radial keratotomy Terrien's marginal degeneration Exclusion Criteria: Corneal thickness < 375 microns measured by ultrasound or Pentacam. Contraindications or hypersensitivities to any study medications or their components. Pregnancy or breastfeeding. Any history of herpes simplex corneal disease in an eye to be treated. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment. Inability to cooperate with diagnostic tests. Enrollment in another ophthalmic clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg J Berdy, MD, FACS
Organizational Affiliation
Ophthalmology Associates, St. Louis, MO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schwartz Laser Eye Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Goodman Eye Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Cornea Consultants of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120-4508
Country
United States
Facility Name
Woolfson Eye Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Chicago Cornea Consultants
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Chicago Cornea Consultants, Ltd.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Cornea Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36173242
Citation
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.
Results Reference
derived

Learn more about this trial

Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

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