KeratoconusPhase 2NCT01956474
CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
A Phase 2 study testing Theralight crosslinking and Riboflavin in people with Keratoconus, run by Cxlusa at 6 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 8 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Theralight crosslinking and Riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,324 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2013to 3 Feb 2017
- Phase
- Phase 2
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 8 years of age or older
- Having at least one of the following conditions:
- Keratoconus
- Post-LASIK ectasia
- Pellucid marginal degeneration
- Forme fruste pellucid marginal degeneration
Show all 12Show fewer
- FFKC
- History of Radial Keratotomy with fluctuating vision.
- Terrien's Marginal Degeneration
- Signed written informed consent and/or assent
- Likely to complete all study visits
- Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.
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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Stulting Research Center at Woolfson Eye Institute
Atlanta, Georgia, 30328
Talamo Hatch Laser Eye Consultants, LLC
Boston, Massachusetts, 02451
Cleveland Eye Clinic
Brecksville, Ohio, 44141
TLC Laser Eye Center
Fairfax, Virginia, 22031
Center for Excellence in Eye Care
Miami, Florida, 33176
TLC Laser Eye Center
Rockville, Maryland, 20852
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.
Read the detailed description
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.
- Conditions
- Keratoconus
- Being tested
- Theralight crosslinking and Riboflavin
- Keywords
- keratoconus, cross-linking, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, FFKC, Radial Keratotomy, Terrien's Marginal Degeneration
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theralight crosslinking and RiboflavinOther
Corneal Collagen cross linking with UV light and riboflavin
| Study group | Role | What they receive |
|---|---|---|
| Theralight crosslinking and Riboflavin | Other | ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin Receives: Other: Theralight crosslinking and Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Spectacle Corrected Visual Acuity (BSCVA)
Measured: 6-9 months
Secondary outcomes (5)
Change in Uncorrected Visual Acuity (UCVA)
Measured: 6-9 months
Change in Corneal topography
Measured: 6-9 months
Change in Manifest Refraction
Measured: 6-9 months
Change in Keratometry on topography and Pentacam
Measured: 6-9 months
Change in Wavefront Refraction and aberrations
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJan 2013
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cxlusa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Trattler, MD, Principal investigator, Cxlusa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956474
- Sponsor's protocol ID
- CXL-04
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2013
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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
- NCT01956474
- Acronym / sponsor ID
- CXL-04
- Conditions
- Keratoconus
- Keywords
- keratoconus, cross-linking, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, FFKC, Radial Keratotomy, Terrien's Marginal Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1,324 participants (actual)
- Lead sponsor
- CxlusaIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 8 Oct 2013 (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.
Detailed description
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theralight crosslinking and Riboflavin | Other | Other: Theralight crosslinking and Riboflavinultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 8 years of age or older
- Having at least one of the following conditions:
- Signed written informed consent and/or assent
- Likely to complete all study visits
- Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.
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 |
|---|---|---|
| Theralight crosslinking and RiboflavinCorneal Collagen cross linking with UV light and riboflavin | Other | Theralight crosslinking and Riboflavin |
Primary outcome
Change in Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 6-9 months
5 secondary outcomes
Change in Uncorrected Visual Acuity (UCVA)
Time frame: 6-9 months
Change in Corneal topography
Time frame: 6-9 months
Change in Manifest Refraction
Time frame: 6-9 months
Change in Keratometry on topography and Pentacam
Time frame: 6-9 months
Change in Wavefront Refraction and aberrations
Time frame: 6-9 months
Results and safety
The study was stopped early. 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
Cxlusa
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Theralight crosslinking and Riboflavin in people with Keratoconus, run by Cxlusa at 6 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 12 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 6 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
Change in Best Spectacle Corrected Visual Acuity (BSCVA) (time frame: 6-9 months). 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.