KeratoconusPhase 3NCT02638376
Evaluating the Safety and Efficacy of the KXL System for Corneal Collagen Cross-Linking in Eyes Having Keratoconus
A Phase 3 study testing 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid) and simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) in people with Keratoconus and Post LASIK Keratectasia, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial summary
The objectives of this study are to evaluate the safety of and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes having: 1. Keratoconus (KC) , 2. Post LASIK ectasia (PLEc) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus, Post LASIK Keratectasia
- What is being tested?
- 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid) and simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2013to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age Limit for for keratoconus and Plec:18 years
- Sign the informed consent.
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
- Contact Lens Wearers Only:
- Minimum of 3 days
- For KC subjects:
Show all 15Show fewer
- Axial topography consistent with keratoconus(Pentacam )
- Presence of central or inferior steepening on the Pentacam map;
- Steepest keratometry (Kmax) value ≥ 47.00 D;
- May have corneal scarring up to and including CLEK grade 4.0 (any scarring up to a dense/opaque stromal scar consistent with KC)
- Keratoconus progressing over time ( evidenced by topography changes, visual acuity or refractive changes)
- For PLEc subjects:
- Having a diagnosis of corneal ectasia after corneal refractive surgery (e.g., LASIK, PRK, epi-LASIK,LASEK,)
- Presence of central or inferior steepening on the Pentacam map.
- Axial topography consistent with corneal ectasia
Who cannot join
- 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 at Visit 2 prior to randomization or during the course of the study;
- For KC and PLEc subjects, corneal pachymetry that is < 400microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated;
- A history of chemical injury or delayed epithelial healing in the eye(s) 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;
Show all 10Show fewer
- Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment,retinoic acid within 6 months of treatment
- Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
- 8.1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.); 8.2. Clinically significant corneal scarring in the cross-linking treatment zone or in the investigator's opinion, will interfere with the cross-linking procedure;
- For KC subjects 9.1. Eyes which are aphakic; 9.2. Eyes that have the maximum corneal curvature (Kmax), as identified and measured by Pentacam, outside of the central 5mm zone; Note: In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.
Trial locations and contacts
1 site in 1 country.
Chuan Teck Ang, Diploma contact
Mohamed Farook Kothubutheen, BSc (Hons) contact
Singapore1 site, 1 recruiting
- Recruiting
Singapore National Eye Centre
Singapore, Singapore, 168751
Chuan Teck Ang, Diploma, ang.chuan.teck@seri.com.sg
Mohamed Farook Kothubutheen, BSc (Hons), farook@snec.com.sg
About this study
Official title: A Study Evaluating the Safety and Efficacy of the KXL System With vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes Having Keratoconus and Post LASIK Ectasia
The objectives of this study are to evaluate the safety of and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes having:
- Keratoconus (KC) ,
- Post LASIK ectasia (PLEc)
Read the detailed description
KC and Plec eyes Group 1 (non-randomised controlled)
Eyes will be assigned into 2 groups:
- Treatment eyes group with KXL
- Control eyes group (fellow eye) The Treatment eyes will be cross linked with the KXL system and the vibeX Rapid Riboflavin, while the control eyes will not receive any treatment.
The safety and efficacy endpoints will be evaluated and compared between the Treatment eye group and the Control eye group.
After 6 months of follow up the KC and PLEc subjects will be offered to treat the control eyes if indicated.
Group 2 (non-randomised controlled combined treatment)
Eyes will be assigned into 2 groups:
- Treatment group with simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)
- Control eyes group (fellow eye) The Treatment eyes will undergo simultaneous topography-guided PRK and be cross linked with the KXL system and the vibeX Rapid Riboflavin, while the control eyes will not receive any treatment.
The safety and efficacy endpoints will be evaluated and compared between the Treatment eye group and the Control eye group.
After 6 months of follow up the KC and PLEc subjects will be offered to treat the control eyes if indicated.
The concentrations of Riboflavin Ophthalmic Solution will be tested - 0.1% Riboflavin ophthalmic solution
KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous treatment or 8 minutes pulse treatment: 1 second on 1 second off.
PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous treatment or 8 minutes pulse treatment: 1 second on 1 second off..
- Conditions
- Keratoconus, Post LASIK Keratectasia
- Being tested
- 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid), simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)
- Keywords
- Keraroconus, keratectasia, treatment
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid)Radiation
KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off.
PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off.
simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)Procedure or surgery
The (Partial, Spherically Corrected) Topography-guided Transepithelial PRK Technique. Is performed with WaveLight® EX 500 excimer laser (Alcon Laboratories Inc, Ft Worth, Texas) customized platform.
This software utilizes topographic data from the linked topography device (Topolyzer; Wave- Light GmbH, Erlangen, Germany). The image of the planned surgery is generated by the laser software.
The topography-guided PRK is used to normalize the cornea by reducing irregular astigmatism while treating part of the refractive error. The maximum ablation depth of stromal ablation is set at 50um.
A 6.5-mm, 50-μm phototherapeutic keratectomy (PTK) was performed to remove the corneal epithelium. Partial topography- guided PRK laser treatment was applied. A cellulose sponge soaked in mitomycin C (MMC) 0.02% solution was applied over the ablated tissue for 20 seconds followed by irrigation with 10 mL of chilled balanced salt solution.
| Study group | Role | What they receive |
|---|---|---|
| KXL treatment only | Active comparator | Not described Receives: Radiation: 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid) |
| KXL and topography-guided PRK | Active comparator | simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) Receives: Radiation: 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid); Procedure: simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measure: Change in Best Corrected Visual Acuity (LogMAR) at 6 months and 1 year
A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes having Keratoconus and post LASIK ectasia
Measured: 6 months and 1 year
Safety measure: change in endothelial cell counts(cells/mm2) at 6 months and 1 year
A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-linking in eyes having keratoconus and LASIK ectasia
Measured: 6 months and 1 year
Efficacy measure: Change in Corneal keratometry measurement, Kmax(D) at 6 months and 1 year
A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-linking in eyes having keratoconus and LASIK ectasia
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lim Li, Singapore Eye Research Institute
- Investigators
- Li Lim, MBBS, FRCS, Principal investigator, Singapore National Eye Centre, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638376
- Sponsor's protocol ID
- R963/72/2012
- Status last verified
- Dec 2015
- First submitted
- 29 Sep 2014
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Safety and Efficacy of the KXL System With vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes Having Keratoconus and Post LASIK Ectasia
- ClinicalTrials.gov ID
- NCT02638376
- Acronym / sponsor ID
- R963/72/2012
- Conditions
- Keratoconus, Post LASIK Keratectasia
- Keywords
- Keraroconus, keratectasia, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 23 Dec 2015 (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 of and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes having:
- Keratoconus (KC) ,
- Post LASIK ectasia (PLEc)
Detailed description
KC and Plec eyes Group 1 (non-randomised controlled)
Eyes will be assigned into 2 groups:
- Treatment eyes group with KXL
- Control eyes group (fellow eye) The Treatment eyes will be cross linked with the KXL system and the vibeX Rapid Riboflavin, while the control eyes will not receive any treatment.
The safety and efficacy endpoints will be evaluated and compared between the Treatment eye group and the Control eye group.
After 6 months of follow up the KC and PLEc subjects will be offered to treat the control eyes if indicated.
Group 2 (non-randomised controlled combined treatment)
Eyes will be assigned into 2 groups:
- Treatment group with simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)
- Control eyes group (fellow eye) The Treatment eyes will undergo simultaneous topography-guided PRK and be cross linked with the KXL system and the vibeX Rapid Riboflavin, while the control eyes will not receive any treatment.
The safety and efficacy endpoints will be evaluated and compared between the Treatment eye group and the Control eye group.
After 6 months of follow up the KC and PLEc subjects will be offered to treat the control eyes if indicated.
The concentrations of Riboflavin Ophthalmic Solution will be tested - 0.1% Riboflavin ophthalmic solution
KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous treatment or 8 minutes pulse treatment: 1 second on 1 second off.
PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous treatment or 8 minutes pulse treatment: 1 second on 1 second off..
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KXL treatment only | Active comparator | Radiation: 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid) |
| KXL and topography-guided PRK | Active comparator | Radiation: 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid), Procedure: simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age Limit for for keratoconus and Plec:18 years
- Sign the informed consent.
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
- Contact Lens Wearers Only:
- Minimum of 3 days
Key exclusion criteria (10 listed)
- 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 at Visit 2 prior to randomization or during the course of the study;
- For KC and PLEc subjects, corneal pachymetry that is < 400microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated;
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated;
- Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
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 |
|---|---|---|
| 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid)KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off. PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off. | Radiation | KXL and topography-guided PRK, KXL treatment only |
| simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)The (Partial, Spherically Corrected) Topography-guided Transepithelial PRK Technique. Is performed with WaveLight® EX 500 excimer laser (Alcon Laboratories Inc, Ft Worth, Texas) customized platform. This software utilizes topographic data from the linked topography device (Topolyzer; Wave- Light GmbH, Erlangen, Germany). The image of the planned surgery is generated by the laser software. The topography-guided PRK is used to normalize the cornea by reducing irregular astigmatism while treating part of the refractive error. The maximum ablation depth of stromal ablation is set at 50um. A 6.5-mm, 50-μm phototherapeutic keratectomy (PTK) was performed to remove the corneal epithelium. Partial topography- guided PRK laser treatment was applied. A cellulose sponge soaked in mitomycin C (MMC) 0.02% solution was applied over the ablated tissue for 20 seconds followed by irrigation with 10 mL of chilled balanced salt solution. | Procedure or surgery | KXL and topography-guided PRK |
Primary outcome
Safety Measure: Change in Best Corrected Visual Acuity (LogMAR) at 6 months and 1 year
Time frame: 6 months and 1 year
A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes having Keratoconus and post LASIK ectasia
Safety measure: change in endothelial cell counts(cells/mm2) at 6 months and 1 year
Time frame: 6 months and 1 year
A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-linking in eyes having keratoconus and LASIK ectasia
Efficacy measure: Change in Corneal keratometry measurement, Kmax(D) at 6 months and 1 year
Time frame: 6 months and 1 year
A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-linking in eyes having keratoconus and LASIK ectasia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
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.
Chuan Teck Ang, Diploma contact
Mohamed Farook Kothubutheen, BSc (Hons) contact
Li Lim, MBBS, FRCS principal investigator
Singapore National Eye Centre, Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid) and simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) in people with Keratoconus and Post LASIK Keratectasia, run by Singapore Eye Research Institute at 1 site in Singapore.
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 15 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuan Teck Ang, Diploma (ang.chuan.teck@seri.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Measure: Change in Best Corrected Visual Acuity (LogMAR) at 6 months and 1 year (time frame: 6 months and 1 year). The study lists 3 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 23 Dec 2015.