Progressive KeratoconusPhase 3CXLNCT00647699
Corneal Collagen Cross-linking for Progressive Keratoconus
A Phase 3 study testing riboflavin ophthalmic solution and UVA Irradiation in people with Progressive Keratoconus, run by Glaukos Corporation at 10 sites in United States.
Trial summary
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Progressive Keratoconus
- What is being tested?
- riboflavin ophthalmic solution and UVA Irradiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2007to Apr 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of keratoconus
- Documented progression over previous 24 months
- Decreased BSCVA
- Must complete all study visits
Who cannot join
- Prior corneal surgery or Intacs
- History of delayed wound healing
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, 21287
Price Vision Group
Indianapolis, Indiana, 46260
Durrie Vision
Kansas City, Kansas, 66211
Shiley Eye Center
La Jolla, California, 92093
Center for Excellence in Eye Care
Miami, Florida, 33176
Minnesota Eye Consultants
Minneapolis, Minnesota, 55404
Edward Harkness Eye Institute at Columbia University Medical Center
New York, New York, 10032
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
Gordon -Weiss Vision Institute
San Diego, California, 91222
Cornea & Laser Eye Institute; Hersh Vision Group
Teaneck, New Jersey, 07666
About this study
Official title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.
Read the detailed description
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.
- Conditions
- Progressive Keratoconus
- Being tested
- riboflavin ophthalmic solution, UVA Irradiation
- Keywords
- keratoconus, cross-linking, riboflavin, UVA light, cornea
- Medical subject headings
- Keratoconus, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
riboflavin ophthalmic solutionDrug
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
UVA IrradiationDevice
Also called UV-X Illumination System
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Corneal Collagen Cross-linking (CXL) Treatment Group | Active comparator | riboflavin ophthalmic solution and UVA irradiation Receives: Drug: riboflavin ophthalmic solution; Device: UVA Irradiation |
| Control Group | Sham comparator | riboflavin ophthalmic solution without UVA irradiation. Receives: Drug: riboflavin ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Maximum Keratometry (Kmax)
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
Measured: baseline,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progressive 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Hersh, MD, Principal investigator, Cornea and Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647699
- Sponsor's protocol ID
- UVX-002
- Acronym
- CXL
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2008
- Last updated
- 26 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02.
PubMed 22692521
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT00647699
- Acronym / sponsor ID
- CXL / UVX-002
- Conditions
- Progressive Keratoconus
- Keywords
- keratoconus, cross-linking, riboflavin, UVA light, cornea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Posted 7 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.
Detailed description
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal Collagen Cross-linking (CXL) Treatment Group | Active comparator | Drug: riboflavin ophthalmic solution, Device: UVA Irradiationriboflavin ophthalmic solution and UVA irradiation |
| Control Group | Sham comparator | Drug: riboflavin ophthalmic solutionriboflavin ophthalmic solution without UVA irradiation. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of keratoconus
- Documented progression over previous 24 months
- Decreased BSCVA
- Must complete all study visits
Key exclusion criteria (2 listed)
- Prior corneal surgery or Intacs
- History of delayed wound healing
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 |
|---|---|---|
| riboflavin ophthalmic solutionriboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) | Drug | Control Group, Corneal Collagen Cross-linking (CXL) Treatment Group |
| UVA IrradiationAlso: UV-X Illumination SystemUVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes | Device | Corneal Collagen Cross-linking (CXL) Treatment Group |
Primary outcome
Mean Change From Baseline in Maximum Keratometry (Kmax)
Time frame: baseline,12 months
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22692521Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02.
Related trials for Progressive Keratoconus
RecruitingPhase 3
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Progressive Keratoconus
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.
Peter Hersh, MD principal investigator
Cornea and Laser Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing riboflavin ophthalmic solution and UVA Irradiation in people with Progressive Keratoconus, run by Glaukos Corporation at 10 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Maximum Keratometry (Kmax) (time frame: baseline,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647699, which also lists 1 linked publication.
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 26 Apr 2021; AzTrials last refreshed its copy on 31 Oct 2026.