Corneal EctasiaPhase 3NCT01643252
Safety and Efficacy Study for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
A Phase 3 study testing riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system in people with Corneal Ectasia, run by Glaukos Corporation.
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
- Corneal Ectasia
- What is being tested?
- riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to not given
- 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 a diagnosis of corneal ectasia after refractive surgery;
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- Having axial topography consistent with corneal ectasia;
- Presence of central or inferior steepening on the Pentacam map;
- 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 the 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;
- A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
- A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be treated;
- Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated;
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- 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 corneal ectasia 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.
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 Corneal Ectasia After Refractive Surgery
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 the detailed description
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
- Corneal Ectasia
- Being tested
- riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system, placebo: 0.0% riboflavin ophthalmic solution with the KXL system
- Keywords
- Corneal Ectasia, Refractive surgery, Cross-Linking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
riboflavin: 0.12% riboflavin ophthalmic solution with the KXL systemDrug
Subjects will receive 0.12% riboflavin ophthalmic solution (VibeX) followed by irradiation with the KXL system at 30mW/cm^2 for 4 minutes
placebo: 0.0% riboflavin ophthalmic solution with the KXL systemDrug
Subjects will receive 0.0% riboflavin ophthalmic solution (placebo) followed by irradiation with the KXL system at 30mW/cm^2 for 4 minutes
| Study group | Role | What they receive |
|---|---|---|
| Placebo and UVA light exposure | Placebo comparator | Not described Receives: Drug: placebo: 0.0% riboflavin ophthalmic solution with the KXL system |
| Riboflavin drops and UVA light exposure | Active comparator | Not described Receives: Drug: riboflavin: 0.12% riboflavin ophthalmic solution with the 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
Safety
The primary safety endpoints are loss of BSCVA beginning at the 6 month follow-up examination, specifically, the percentage of eyes that have a loss of 15 or more letters in BSCVA on the ETDRS chart as compared to baseline and the incidence of serious ophthalmic adverse events.
Measured: 12 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 posted18 Jul 2012 (estimated)
- Study startJul 2012
Why it stopped: This study was withdrawn for business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EctasiaStudies 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
- 0 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
- NCT01643252
- Sponsor's protocol ID
- KXL-003
- Status last verified
- Apr 2021
- First submitted
- 16 Jul 2012
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 Corneal Ectasia After Refractive Surgery
- ClinicalTrials.gov ID
- NCT01643252
- Acronym / sponsor ID
- KXL-003
- Conditions
- Corneal Ectasia
- Keywords
- Corneal Ectasia, Refractive surgery, Cross-Linking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn for business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- First posted
- 18 Jul 2012 (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.
Detailed description
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 |
|---|---|---|
| Placebo and UVA light exposure | Placebo comparator | Drug: placebo: 0.0% riboflavin ophthalmic solution with the KXL system |
| Riboflavin drops and UVA light exposure | Active comparator | Drug: riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 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 a diagnosis of corneal ectasia after refractive surgery;
Key exclusion criteria (19 listed)
- Patients must not meet any of the 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;
- A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
- A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) 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: 0.12% riboflavin ophthalmic solution with the KXL systemSubjects will receive 0.12% riboflavin ophthalmic solution (VibeX) followed by irradiation with the KXL system at 30mW/cm^2 for 4 minutes | Drug | Riboflavin drops and UVA light exposure |
| placebo: 0.0% riboflavin ophthalmic solution with the KXL systemSubjects will receive 0.0% riboflavin ophthalmic solution (placebo) followed by irradiation with the KXL system at 30mW/cm^2 for 4 minutes | Drug | Placebo and UVA light exposure |
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
Safety
Time frame: 12 months
The primary safety endpoints are loss of BSCVA beginning at the 6 month follow-up examination, specifically, the percentage of eyes that have a loss of 15 or more letters in BSCVA on the ETDRS chart as compared to baseline and the incidence of serious ophthalmic adverse events.
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
Related trials for Corneal Ectasia
RecruitingObservational study
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Corneal Elastography and Patient Specific Modeling
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system in people with Corneal Ectasia, run by Glaukos Corporation.
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 11 inclusion and 19 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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). The study lists 2 primary outcomes in all. 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.