KeratoconusPhase 3NCT01344187
Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus
A Phase 3 study testing riboflavin solution and KXL System in people with Keratoconus, run by Glaukos Corporation at 10 sites in United States.
Trial summary
The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- riboflavin solution and KXL System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2012to Jun 2016
- Phase
- Phase 3
- 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
Who may be able to join
- Patients must meet all of the following criteria in order to be enrolled into the trial:
- Be at least 12 years of age, male or female, of any race;
- Provide written informed consent and sign a HIPAA form. Patients who are under the age of 18 will need to sign an assent form as well as having a parent or legal guardian sign an informed consent;
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of the study eye and prior to treatment of a fellow and/or cross-over eye; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit, one week prior to treatment of a fellow eye or cross-over eye, and continue to use the method for one month following the last treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
- Having topographic evidence of keratoconus with a diagnosis of mild, moderate, or severe keratoconus defined as the following:
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- Mild Keratoconus:
- Axial topography consistent with keratoconus
- Flat Pentacam keratometry reading ≤ 51.00D
- Moderate Keratoconus:
- Axial topography consistent with keratoconus
- Flat Pentacam keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00 D
- Severe Keratoconus:
- Axial topography consistent with keratoconus with marked areas of steepening
- Flat Pentacam keratometry reading ≥ 56.01 D
- Presence of central or inferior steepening on the Pentacam map;
- Have a maximum corneal curvature, as measured by Kmax of ≥ 47.00 D;
- BSCVA (Best Spectacle Corrected Visual Acuity) of ≥ 1 letter and ≤ 80 letters on ETDRS (Early Treatment of Diabetic Retinopathy Study) chart;
- Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the screening visit(s);
- Contact Lens Wearers Only: Manifest refraction must be stable between two visits which occur at least 7 days apart. A stable refraction is one in which the manifest refraction spherical equivalent and the average K (Km) on the Pentacam taken at the first visit do not differ by more than 0.75 D from the respective measurements taken at the second exam.
Who cannot join
- Patients must not meet any of he following criteria in order to be enrolled into the trial:
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
- If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme;
- A history of previous corneal surgery or the insertion of Intacs in the eye to be treated;
- A history of previous Limbal Relaxing Incision (LRI) procedure in the eye to be treated;
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- Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated;
- Eyes which are aphakic;
- Eyes which are pseudophakic and do not have a UV blocking lens implanted;
- Eyes that have the maximum corneal curvature (Kmax) outside of the central 5mm zone as measured by the Pentacam;
- Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
- For example:
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.);
- Clinically significant corneal scarring in the cross-linking treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure;
- A history of delayed epithelial healing in the eye to be treated;
- Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;
- Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- A history of previous corneal crosslinking treatment in the eye to be treated;
- Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device trial within 30 days of the study;
- In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory Eye Center
Atlanta, Georgia, 30342
Hoopes Vision
Draper, Utah, 84020
UC Irvine Department of Ophthalmology
Irvine, California, 92697
Bascolm Palmer Eye Institute
Miami, Florida, 33136
Medical University of South Carolina Storm Eye Institute, Magill Vision Center
Mt. Pleasant, South Carolina, 29464
Kugler Vision
Omaha, Nebraska, 68144
Pinceton Eye Goup
Princeton, New Jersey, 08540
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Ophthalmic Consultants of Boston
Waltham, Massachusetts, 02451
Comprehensive Eye Care of Central Ohio
Westerville, Ohio, 43082
About this study
Official title: A Multi-Center, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus
The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.
- Conditions
- Keratoconus
- Being tested
- riboflavin solution, placebo solution, KXL System
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
riboflavin solutionDrug
Also called VibeX
0.12% riboflavin ophthalmic solution
placebo solutionDrug
Also called placebo
0.0% riboflavin ophthalmic solution
KXL SystemDevice
Also called UVA Irradiation
30 mW/cm2
| Study group | Role | What they receive |
|---|---|---|
| riboflavin solution and KXL System | Experimental | Subjects will receive riboflavin solution followed by UVA irradiation for 4 minutes Receives: Drug: riboflavin solution; Device: KXL System |
| placebo solution and KXL System | Placebo comparator | Subjects will receive placebo solution followed by UVA irradiation for 4 minutes Receives: Drug: placebo solution; Device: KXL System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group
Measured: baseline to 6 months
Secondary outcomes (1)
Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionJun 2016
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.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vineeta Belanger, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344187
- Sponsor's protocol ID
- KXL-001
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2011
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- A Multi-Center, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus
- ClinicalTrials.gov ID
- NCT01344187
- Acronym / sponsor ID
- KXL-001
- Conditions
- Keratoconus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Apr 2011 (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 objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| riboflavin solution and KXL System | Experimental | Drug: riboflavin solution, Device: KXL SystemSubjects will receive riboflavin solution followed by UVA irradiation for 4 minutes |
| placebo solution and KXL System | Placebo comparator | Drug: placebo solution, Device: KXL SystemSubjects will receive placebo solution followed by UVA irradiation for 4 minutes |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Be at least 12 years of age, male or female, of any race;
- Provide written informed consent and sign a HIPAA form. Patients who are under the age of 18 will need to sign an assent form as well as having a parent or legal guardian sign an informed consent;
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of the study eye and prior to treatment of a fellow and/or cross-over eye; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit, one week prior to treatment of a fellow eye or cross-over eye, and continue to use the method for one month following the last treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
- Having topographic evidence of keratoconus with a diagnosis of mild, moderate, or severe keratoconus defined as the following:
Key exclusion criteria (21 listed)
- Patients must not meet any of he following criteria in order to be enrolled into the trial:
- Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
- If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme;
- A history of previous corneal surgery or the insertion of Intacs in the eye to be treated;
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 solutionAlso: VibeX0.12% riboflavin ophthalmic solution | Drug | riboflavin solution and KXL System |
| placebo solutionAlso: placebo0.0% riboflavin ophthalmic solution | Drug | placebo solution and KXL System |
| KXL SystemAlso: UVA Irradiation30 mW/cm2 | Device | placebo solution and KXL System, riboflavin solution and KXL System |
Primary outcome
Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group
Time frame: baseline to 6 months
1 secondary outcome
Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group
Time frame: baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Vineeta Belanger study director
Glaukos Corporation
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 solution and KXL System in people with 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 20 inclusion and 21 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group (time frame: baseline to 6 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 26 Apr 2021.