KeratoconusNCT01189864
Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas
An observational study of Keratoconus and Ectasia, run by Cxlusa at 16 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keratoconus, Ectasia, Degeneration
- What is being tested?
- Ciprofloxicin or Vigamox or other., Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc) and Steroid (FML, Pred Forte, Flarex, etc.)
- How many people
- 3,493 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Feb 2010to 3 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic.
Who may be able to join
- 12 years of age or older
- Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
- Diagnosis of FFKC
- History of Radial Keratotomy with fluctuating vision
- Ability to provide written informed consent
- Likely to complete all study visits
- Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam
- At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)
Who cannot join
- Severe corneal scarring that markedly affects vision
- Contraindications to any study medications or their components
- Pregnancy or breast feeding
- Active Herpes Corneal Disease
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Cleveland Eye Clinic
Brecksville, Ohio, 44141
TLC Laser Eye Center
Fairfax, Virginia, 22031
Chicago Cornea Consultants, LTD
Hoffman Estates, Illinois, 60169
Harvard Eye Associates
Laguna Hills, California
Corneal Consultants of Colorado, P.C
Littleton, Colorado
The Center for Excellence in Eye Care
Miami, Florida, 33176
TLC Laser Eye Center
Rockville, Maryland, 20852
Clear View Eye & Laser Medical Center
San Diego, California
Study site
San Francisco, California
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
Northwest Eye Surgeons
Seattle, Washington
Empire Eye Physicians
Spokane Valley, Washington
Ophthalomology Associates
St Louis, Missouri
Talamo Laser Eye Center
Waltham, Massachusetts
South Shore Eye Care LLP
Wantagh, New York, 11793
Davidorf Eye Group
West Hills, California
About this study
Official title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.
- Conditions
- Keratoconus, Ectasia, Degeneration
- Being tested
- Ciprofloxicin or Vigamox or other., Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc), Steroid (FML, Pred Forte, Flarex, etc.)
- Medical subject headings
- Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxicin or Vigamox or other.Drug
Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)Drug
Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.)Drug
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxicin or Vigamox or other. | Not described Receives: Drug: Ciprofloxicin or Vigamox or other. | |
| Nonsteroidal (Acular, Voltaren Xibrom, etc) | Not described Receives: Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc) | |
| Steroid (FML, Pred Forte, Flarex, etc.) | Not described Receives: Drug: Steroid (FML, Pred Forte, Flarex, etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
Measured: 1 year
Secondary outcomes (1)
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study start1 Feb 2010
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
Why it stopped: Terminated to initiate FDA IND-cleared study protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cxlusa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Trattler, MD, Principal investigator, The Center for Excellence in Eye CareJodi Luchs, MD, Principal investigator, South Shore Eye Care LLPShamik Bafna, MD, Principal investigator, Cleveland Eye ClinicParag Majmudar, MD, Principal investigator, Chicago Cornea Consultants, LTDJay Schwartz, MD, Principal investigator, Schwartz Laser Eye CenterJonathan Davidorf, MD, Principal investigator, Davidorf Eye GroupDaniel Goodman, MD, Principal investigator, Goodman Eye CenterJonathan Talamo, MD, Principal investigator, Talamo Laser Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189864
- Sponsor's protocol ID
- CXL (12 & older)
- Status last verified
- Sep 2018
- First submitted
- 20 Jul 2010
- Last updated
- 12 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
- ClinicalTrials.gov ID
- NCT01189864
- Acronym / sponsor ID
- CXL (12 & older)
- Conditions
- Keratoconus, Ectasia, Degeneration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated to initiate FDA IND-cleared study protocol
- Enrolment
- 3,493 participants (actual)
- Lead sponsor
- CxlusaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxicin or Vigamox or other. | – | Drug: Ciprofloxicin or Vigamox or other. |
| Nonsteroidal (Acular, Voltaren Xibrom, etc) | – | Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc) |
| Steroid (FML, Pred Forte, Flarex, etc.) | – | Drug: Steroid (FML, Pred Forte, Flarex, etc.) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic.
Key inclusion criteria (8 listed)
- 12 years of age or older
- Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
- Diagnosis of FFKC
- History of Radial Keratotomy with fluctuating vision
- Ability to provide written informed consent
Key exclusion criteria (4 listed)
- Severe corneal scarring that markedly affects vision
- Contraindications to any study medications or their components
- Pregnancy or breast feeding
- Active Herpes Corneal Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxicin or Vigamox or other.Ciprofloxicin or Vigamox or other to be used qid till epithelialized. | Drug | Ciprofloxicin or Vigamox or other. |
| Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op | Drug | Nonsteroidal (Acular, Voltaren Xibrom, etc) |
| Steroid (FML, Pred Forte, Flarex, etc.)Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks. | Drug | Steroid (FML, Pred Forte, Flarex, etc.) |
Primary outcome
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
Time frame: 1 year
1 secondary outcome
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Terminated to initiate FDA IND-cleared study protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Trattler, MD principal investigator
The Center for Excellence in Eye Care
Jodi Luchs, MD principal investigator
South Shore Eye Care LLP
Shamik Bafna, MD principal investigator
Cleveland Eye Clinic
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus and Ectasia, run by Cxlusa at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated to initiate FDA IND-cleared study protocol). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.