KeratoconusPhase 3NCT03858036
Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders
A Phase 3 study testing Ricrolin+ and VEGA UV-A system in people with Keratoconus and Ectasia, run by Center for Sight, Sacramento, CA at 1 site in United States.
Trial summary
This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keratoconus, Ectasia
- What is being tested?
- Ricrolin+ and VEGA UV-A system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 31 Dec 2024
- 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
- Be at least 12 years of age or older, male or female, of any race.
- Having a diagnosis of keratoconus or other corneal ectatic disorder.
- Presence of central or inferior steepening on the topography map.
- Axial topography consistent with keratoconus or other corneal ectatic disorder.
- For eyes diagnosed with keratoconus, presence of one or more slit lamp findings associated with keratoconus, such as:
- Scissoring of the retinoscopic reflex
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- Fleischer ring
- Vogt striae
- Corneal thinning e .Corneal scarring
- BSCVA 20/20 or worse.
- Subject is willing to have CXL performed by the Epi-OFF or Epi-ON techniques.
- Provide written informed consent and a signed HIPPA form. Pediatric subjects less than 14 years of age must sign an assent and a parent or legal guardian must sign an informed consent.
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits.
- If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue o one month following treatment.
Who cannot join
- One of the randomized CXL techniques (Epi-OFF or Epi-ON) is contraindicated or, in the investigator's clinical judgment, is not able to be performed in the study eye.
- Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices.
- A history of previous corneal transplant in the study eye.
- A history of prior CXL in the study eye.
- Corneal pachymetry < 375 microns at the thinnest point as measured by ultrasound pachymetry in the study eye before epithelium removal. [NOTE: Eyes with corneal pachymetry between <375 microns and 325 microns may be enrolled in the compassionate use group.]
- Presence of Intacs or corneal rings or segments in the study eye.
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- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example:
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
- Clinically significant corneal scarring in the treatment zone unrelated to keratoconus.
- Eyes which are aphakic.
- Eyes which are pseudophakic and do not have a UV blocking lens implanted.
- A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
- Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests.
- If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of, either eye during the course of the study.
- A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing, including a history of chemical injury or delayed epithelial healing in the study eye.
- Presence or history or any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Sight
Sacramento, California, 95816
Jasmine Ly, OD, 916-446-2020, jly@liangvision.com
Keith Liang, MD
About this study
Official title: Comparison of Corneal Collagen Cross-Linking Performed With "Epi-ON" Versus "Epi-OFF" Techniques in Eyes With Keratoconus and Other Corneal Ectatic Disorders
This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.
- Conditions
- Keratoconus, Ectasia
- Being tested
- Ricrolin+, VEGA UV-A system
- Medical subject headings
- Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ricrolin+Drug
1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete.
VEGA UV-A systemDevice
The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.
| Study group | Role | What they receive |
|---|---|---|
| Epi-OFF CXL | Active comparator | The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment. Receives: Drug: Ricrolin+; Device: VEGA UV-A system |
| Epi-ON CXL | Active comparator | The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment. Receives: Drug: Ricrolin+; Device: VEGA UV-A system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in corneal curvature
Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III
Measured: Baseline, 6 Months, and 12 Months
Secondary outcomes (4)
Change in manifest refraction spherical equivalent
Change in refraction
Measured: Baseline, 6 Months, and 12 Months
Change in best-corrected visual acuity (BSCVA)
Percentage of eyes that had a loss of 2 or more lines in BSCVA
Measured: Baseline, 6 Months, and 12 Months
Change in uncorrected-visual acuity (UCVA)
Measured: Baseline, 6 Months, and 12 Months
Change in thinnest pachymetry
measured by ultrasound
Measured: Baseline, 6 Months, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start8 Mar 2019 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Sight, Sacramento, CA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858036
- Sponsor's protocol ID
- CFS-CXL-001
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Corneal Collagen Cross-Linking Performed With "Epi-ON" Versus "Epi-OFF" Techniques in Eyes With Keratoconus and Other Corneal Ectatic Disorders
- ClinicalTrials.gov ID
- NCT03858036
- Acronym / sponsor ID
- CFS-CXL-001
- Conditions
- Keratoconus, Ectasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Center for Sight, Sacramento, CAUniversity, hospital or other
- Study start
- 8 Mar 2019 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 2019 (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.
This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epi-OFF CXL | Active comparator | Drug: Ricrolin+, Device: VEGA UV-A systemThe Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment. |
| Epi-ON CXL | Active comparator | Drug: Ricrolin+, Device: VEGA UV-A systemThe Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Be at least 12 years of age or older, male or female, of any race.
- Having a diagnosis of keratoconus or other corneal ectatic disorder.
- Presence of central or inferior steepening on the topography map.
- Axial topography consistent with keratoconus or other corneal ectatic disorder.
- For eyes diagnosed with keratoconus, presence of one or more slit lamp findings associated with keratoconus, such as:
Key exclusion criteria (16 listed)
- One of the randomized CXL techniques (Epi-OFF or Epi-ON) is contraindicated or, in the investigator's clinical judgment, is not able to be performed in the study eye.
- Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices.
- A history of previous corneal transplant in the study eye.
- A history of prior CXL in the study eye.
- Corneal pachymetry < 375 microns at the thinnest point as measured by ultrasound pachymetry in the study eye before epithelium removal. [NOTE: Eyes with corneal pachymetry between <375 microns and 325 microns may be enrolled in the compassionate use group.]
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 |
|---|---|---|
| Ricrolin+1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete. | Drug | Epi-OFF CXL, Epi-ON CXL |
| VEGA UV-A systemThe VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration. | Device | Epi-OFF CXL, Epi-ON CXL |
Primary outcome
Mean change in corneal curvature
Time frame: Baseline, 6 Months, and 12 Months
Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III
4 secondary outcomes
Change in manifest refraction spherical equivalent
Time frame: Baseline, 6 Months, and 12 Months
Change in best-corrected visual acuity (BSCVA)
Time frame: Baseline, 6 Months, and 12 Months
Change in uncorrected-visual acuity (UCVA)
Time frame: Baseline, 6 Months, and 12 Months
Change in thinnest pachymetry
Time frame: Baseline, 6 Months, and 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- 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.
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 Ricrolin+ and VEGA UV-A system in people with Keratoconus and Ectasia, run by Center for Sight, Sacramento, CA 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 14 inclusion and 16 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 28 Feb 2019. 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 Jasmine Ly, OD (916-446-2020, jly@liangvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in corneal curvature (time frame: Baseline, 6 Months, and 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 28 Feb 2019.