KeratoconusPhase 3NCT04905108
Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia
A Phase 3 study testing Riboflavin in people with Keratoconus and Corneal Ectasia, run by Cornea and Laser Eye Institute at 1 site in United States.
Trial summary
Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Corneal Ectasia
- What is being tested?
- Riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to Dec 2025
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older
- Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK])
- Presence of central or inferior steepening on the Pentacam map
- Axial topography consistent with keratoconus or post-surgical corneal ectasia
- Contact lens wearers only: Removal of contact lenses for the required period of 1 week prior to the screening refraction
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
Who cannot join
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
- Corneal pachymetry measuring 300 microns or less at the thinnest point measured by Pentacam in the eye(s) to be treated
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
- Clinically significant corneal scaring in the CXL treatment zone
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
Show all 10Show fewer
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
- Patients with a current condition that,in the investigator's opinion, would interfere with or prolong epithelial healing
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cornea and Laser Eye Institute, Hersh Vision Group
Teaneck, New Jersey, 07666
BethAnn Hibbert, 201-692-9434, bfurlong-hibbert@vision-institute.com
Stacey Lazar, 201 692-434, slazar@vision-institute.om
About this study
Official title: Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Two Different Riboflavin Administration Protocols
Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.
Read the detailed description
The objective of this randomized study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with two different riboflavin administration protocols during the UVA portion of the procedure. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, the two groups will be compared with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, and slit lamp examination.
- Conditions
- Keratoconus, Corneal Ectasia
- Being tested
- Riboflavin
- Keywords
- keratoconus, corneal ectasia, collagen crosslinking, riboflavin, crosslinking, corneal crosslinking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinDrug
Administration of riboflavin one drop every 2 minutes during UVA exposure
RiboflavinDrug
Administration of riboflavin one drop every 10 minutes during UVA exposure
| Study group | Role | What they receive |
|---|---|---|
| Riboflavin drop every 2 minutes | Active comparator | Administration of one drop of Riboflavin every 2 minutes during UV exposure Receives: Drug: Riboflavin |
| Riboflavin drop every 10 minutes | Active comparator | Administration of one drop of Riboflavin every 10 minutes during UV exposure Receives: Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum keratometry
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.
Measured: 12 months
Secondary outcomes (1)
Mean keratometry
The change in mean keratometry (Mean K) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start2 Jun 2021
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornea and Laser Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter S Hersh, MD, Study director, Cornea and Laser Eye Institute - Hersh Vision GroupSteven A Greenstein, MD, Principal investigator, Cornea and Laser Eye Institute - Hersh Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905108
- Sponsor's protocol ID
- TE-CXL-002
- Status last verified
- Dec 2022
- First submitted
- 24 May 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Two Different Riboflavin Administration Protocols
- ClinicalTrials.gov ID
- NCT04905108
- Acronym / sponsor ID
- TE-CXL-002
- Conditions
- Keratoconus, Corneal Ectasia
- Keywords
- keratoconus, corneal ectasia, collagen crosslinking, riboflavin, crosslinking, corneal crosslinking
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cornea and Laser Eye InstituteUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 May 2021 (actual)
- 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.
Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.
Detailed description
The objective of this randomized study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with two different riboflavin administration protocols during the UVA portion of the procedure. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, the two groups will be compared with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, and slit lamp examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riboflavin drop every 2 minutes | Active comparator | Drug: RiboflavinAdministration of one drop of Riboflavin every 2 minutes during UV exposure |
| Riboflavin drop every 10 minutes | Active comparator | Drug: RiboflavinAdministration of one drop of Riboflavin every 10 minutes during UV exposure |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 12 years of age or older
- Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK])
- Presence of central or inferior steepening on the Pentacam map
- Axial topography consistent with keratoconus or post-surgical corneal ectasia
- Contact lens wearers only: Removal of contact lenses for the required period of 1 week prior to the screening refraction
Key exclusion criteria (10 listed)
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
- Corneal pachymetry measuring 300 microns or less at the thinnest point measured by Pentacam in the eye(s) to be treated
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
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 |
|---|---|---|
| RiboflavinAdministration of riboflavin one drop every 2 minutes during UVA exposure | Drug | Riboflavin drop every 10 minutes |
| RiboflavinAdministration of riboflavin one drop every 10 minutes during UVA exposure | Drug | Riboflavin drop every 2 minutes |
Primary outcome
Maximum keratometry
Time frame: 12 months
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.
1 secondary outcome
Mean keratometry
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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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.
Peter S Hersh, MD study director
Cornea and Laser Eye Institute - Hersh Vision Group
Steven A Greenstein, MD principal investigator
Cornea and Laser Eye Institute - Hersh Vision Group
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 Riboflavin in people with Keratoconus and Corneal Ectasia, run by Cornea and Laser Eye Institute at 1 site 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 7 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 4 Jan 2023. 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 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 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 BethAnn Furlong-HIbbert ((201) 692-9434, bfurlong-hibbert@vision-institute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum keratometry (time frame: 12 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 4 Jan 2023.