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Trial record 1 of 1 for:    CXL005
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COLLAGEN CROSS-LINKING WITH ULTRAVIOLET-A IN ASYMMETRIC CORNEAS

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ClinicalTrials.gov Identifier: NCT03029104
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Cxlusa

Brief Summary:
This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.

Condition or disease Intervention/treatment Phase
Keratoconus Corneal Diseases Eye Diseases Photosensitizing Agents Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: COLLAGEN CROSS-LINKING WITH ULTRAVIOLET-A IN ASYMMETRIC CORNEAS
Actual Study Start Date : December 21, 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: 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.
Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution

Active Comparator: 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.
Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution

Active Comparator: 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.
Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution




Primary Outcome Measures :
  1. Corrected Distance Visual Acuity (CDVA) [ Time Frame: 6 months ]
    Change in corrected distance visual acuity (CDVA) compared to baseline


Secondary Outcome Measures :
  1. Uncorrected distance visual acuity (UCVA) [ Time Frame: 6 months ]

    Change in uncorrected distance visual acuity (UCVA) compared to baseline

    Secondary: Change at 6 months as compared to baseline in:

    1. Uncorrected distance visual acuity
    2. KMax

  2. KMax [ Time Frame: 6 months ]
    Change in Kmax compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029104


Contacts
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Contact: Debi S Gravemann, RN (314) 966-3377 dg@cxlusa.com
Contact: Roxanne Littner, MS (202) 791-0374 roxannelittner@gmail.com

Locations
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United States, Arizona
Schwartz Laser Eye Center Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Jay L Schwartz, D.O.    480-483-3937      
United States, California
Goodman Eye Center Recruiting
San Francisco, California, United States, 94115
Contact: Kristen Symon    415-474-3333    ksymon@goodmaneyecenter.com   
Principal Investigator: Dan Goodman, MD         
United States, Colorado
Cornea Consultants of Colorado Recruiting
Littleton, Colorado, United States, 80120-4508
Contact: Breanna Nickels    720-709-7533    bnickels@corneaonline.com   
Principal Investigator: S. Lance Forstot, MD         
United States, Georgia
Woolfson Eye Institute Recruiting
Atlanta, Georgia, United States, 30328
Contact: Doyle Stulting, MD, PhD    770-740-0233      
Principal Investigator: Doyle Stulting, MD, PhD         
Sub-Investigator: Johathan M Woolfson, MD         
United States, Illinois
Chicago Cornea Consultants Recruiting
Chicago, Illinois, United States, 60035
Contact: Dennis Nguyen    847-432-6010    dNguyen@chicagocornea.com   
Principal Investigator: Randy Epstein, MD         
Chicago Cornea Consultants, Ltd. Recruiting
Hoffman Estates, Illinois, United States, 60169
Contact: Jim Nykaza    847-432-6010    jimn@chicagocornea.com   
Principal Investigator: Parag A Majmudar, MD         
Sub-Investigator: Randy J Epstein, MD         
Sub-Investigator: Maria E Rosselson, MD         
United States, Missouri
Ophthalmology Associates Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Gregg J Berdy, MD, FACS    314-966-5000      
Contact: Debi Gravemann, RN    (314) 966-3377    dg@cxlusa.com   
Principal Investigator: Gregg J Berdy, MD         
United States, Ohio
Cleveland Eye Clinic Recruiting
Brecksville, Ohio, United States, 44141
Contact: Erin Kuskridler    216-503-6535    kus-kridler@clearchoicelaser.com   
Principal Investigator: Shamik Bafna, MD         
United States, Texas
Cornea Associates of Texas Recruiting
Dallas, Texas, United States, 75231
Contact: Jennifer Raines    214-692-0146    jraines@corneatexas.com   
Principal Investigator: Brad Bowman, MD         
Sponsors and Collaborators
Cxlusa
Investigators
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Principal Investigator: Gregg J Berdy, MD, FACS Ophthalmology Associates, St. Louis, MO

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Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT03029104     History of Changes
Other Study ID Numbers: CXL-005
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Cxlusa:
Keratoconus
Forme fruste keratoconus
Post-LASIK ectasia
Pellucid marginal degeneration
Forme fruste pellucid marginal degeneration
Diurnal fluctuation post-radial keratotomy
Terrien's marginal degeneration

Additional relevant MeSH terms:
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Eye Diseases
Keratoconus
Corneal Diseases
Dermatitis, Phototoxic
Dermatitis, Irritant
Dermatitis, Contact
Dermatitis
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Pharmaceutical Solutions