KeratitisPhase 2/3NCT05255107
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers
A Phase 2/3 study of Keratitis and Corneal Ulcer, run by Peschke GmbH at 12 sites in United States.
Trial summary
This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal collagen crosslinking (CXL) for the treatment of previously untreated corneal ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratitis, Corneal Ulcer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 12 sitesUnited States
- Study dates
- 14 Mar 2022to 24 Feb 2024
- Phase
- Phase 2/3
- 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
- Subjects who have one or both eyes that meet the following criteria will be considered candidates for this study:
- 18 years of age or older
- Ulcers that have not been treated with ophthalmic antibiotic eyedrops (eg, quinolone, polymyxin/trimethoprim, erythromycin, vancomycin, tobramycin, cefazolin, or other ophthalmic antimicrobials) in the preceding 30 days erythromycin, vancomycin, tobramycin, cefazolin, or other ophthalmic antimicrobials) in the preceding 30 days
- Consent to a corneal culture for suspected bacterial keratitis (defined as a corneal epithelial defect of any size with an infiltration of the underlying stroma)
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Minimum corneal thickness >300 μm
Who cannot join
- All subjects meeting any of the following criteria will be excluded from this study:
- Presence of a perforated corneal ulcer
- Presence of a corneal ulcer that had produced a descemetocele
- Presence of a corneal ulcer deeper than 50% depth or 275 μm in the cornea
- Any active ocular infection other than the corneal ulcer to be treated
- Suspicion of amoebic or viral keratitis requiring treatment with topical anti-amoebic or topical antiviral ophthalmic medications
Show all 11Show fewer
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye(s) for future complications. This may include history of or active corneal disease (eg, herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
- Uncontrolled systemic disease, especially a collagen-vascular or rheumatologic condition that could be contributing to the corneal condition
- Pregnancy (or plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Presence of nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
SightMD
Babylon, New York, 11702
Eric Rosenberg, MD, ericr29@gmail.com
Kathleen LeMier, (631)957-3355
- Recruiting
Woolfson Eye
Chattanooga, Tennessee, 37421
Jonathan Woolfson, MD, jwoolfson@woolfsoneye.com
Deborah Alexander-Davis, dadavis@woolfsoneye.com
- Recruiting
Prisma Health Opthalmology
Columbia, South Carolina, 29203
Shawn Iverson, MD, Shawn.Iverson2@prismahealth.org
- Recruiting
Gorovoy M.D Eye Specialists
Fort Myers, Florida, 33907
Mark Gorovoy, MD, mgorovoy@gorovoyeye.com
Carrie Soto, (239) 939-1444
- Recruiting
Houston Eye Associates
Houston, Texas, 77008
John Goosey, MD
Marcel Belloso, (832) 553-7100
- Recruiting
Price Vision Group
Indianapolis, Indiana, 46260
Francis Price, MD, francisprice@pricevisiongroup.net
Marianne Price, marianneprice@cornea.org
- Recruiting
San Antonio Eye Center
Lackland Air Force Base, Texas, 78236
Vasudha Panday, MD, vasudhapanday@hotmail.com
- Recruiting
Colorado Eye Consultants
Littleton, Colorado, 80120
Lance Forstot, MD, SL4STOT@aol.com
Shivam Patel, (303) 730-0404
- Recruiting
Milwaukee Eye Surgeons
Milwaukee, Wisconsin, 53203
Kenneth Weinlander, kweinlander@milwaukeeeyesurgeons.com
Cherry Marquez, (414) 377-5550
- Recruiting
Valley Eye
Oshkosh, Wisconsin, 54901
Michael Vrabec, MD, michael.vrabec@thedacare.org
Cherie Mader, (920) 749-4064, cherie.mader@thedacare.org
- Recruiting
Bay Area Eye Institute
Tampa, Florida, 33613
Craig Berger, MD, craigbergermd@gmail.com
Lisa Oliveri, (813) 265-6940
- Recruiting
The cornea & Laser Eye Institute-NJ
Teaneck, New Jersey, 07666
Peter Hersh, MD, phersh@vision-institute.com
BethAnn Furlong-Hibbert, (201) 692-9434, bfurlong-hibbert@vision-institute.com
About this study
This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal collagen crosslinking (CXL) for the treatment of previously untreated corneal ulcers. The PXL Platinum 330 System is a combination product consisting of an ultraviolet A (UV-A) 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Riboflavin 0.23% PESCHKE-L Solution) administered in conjunction with the UV-A light as a photosensitizer. The PXL Platinum 330 System is intended to induce corneal collagen CXL to improve the biomechanical properties of the cornea by strengthening the corneal tissue in the anterior stroma. Corneal collagen CXL is performed by pretreating the cornea with riboflavin ophthalmic solution beginning 40 min before UV-A light exposure to saturate the corneal tissue with the riboflavin photosensitizer. The cornea is then irradiated with UV-A light (365 nm) at an irradiance of 18 mW/cm2 (5 seconds on, 5 seconds off) for 10 min. Exposure of the cornea to this UV-A light regimen after topical administration of riboflavin ophthalmic solution has been shown to induce CXL of the corneal collagen fibrils, with a resultant increase in tensile strength and diameter of the collagen fibrils. Clinically, CXL has been shown to stabilize the corneal curvature in eyes with progressive keratoconus, with no significant change in the refractive index of the cornea. Numerous reports and a few clinical trials have also shown benefit in aiding resolution of infective corneal ulcers.
Read the detailed description
This is a prospective, 2-arm parallel-group, single-masked, randomized multicenter study to determine the safety and effectiveness of the PXL Platinum 330 System for performing CXL in eyes with previously untreated corneal ulcers. Subjects with documented infectious corneal ulcers that have not been treated (treatment na ve) will be evaluated initially for suitability as candidates for CXL. Subjects who are candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required study procedures that are not part of the investigator's routine examination. After completing screening procedures, the diagnosis for each eligible eye will be confirmed. Subjects will be randomized to 1 of 2 groups, both including standard of care (SOC) treatment:
- SOC: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion
- CXL + SOC: Moxifloxacin 0.5% eyedrop therapy + CXL
Eyes undergoing CXL will have topical anesthetic administered and then have topical riboflavin instilled onto the cornea every 2 min (or longer as needed to assure adequate corneal penetration), after which the cornea will be exposed to UV-A pulsed light 18 mW/cm2 for 10 min. Riboflavin instillation will continue every 2 min during CXL. The CXL procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UV-A light source and riboflavin solution). All use of the PXL Platinum 330 System will be in accordance with this protocol and the general instructions provided by the manufacturer (PESCHKE) in the PXL Platinum 330 Illumination System Operator's Manual. All subjects will be evaluated at Screening/Baseline, Day 0 (Randomization/Treatment), Day 1, Day 3 ( 1 day), Week 1 ( 2 days), Week 2 ( 2 days), and Week 4 ( 3 days) after treatment. Efficacy monitoring throughout the study will include observations at appropriate times for re-epithelialization, size of infection, and corneal culture results. Safety monitoring throughout the study will include observations at appropriate times for pain, IOP, BSCVA, corneal scar size, AEs, clinically significant findings on ophthalmic examination, dilated fundus examination, and slit lamp examination. After treatment, subjects will be followed at the treating physician's discretion.
- Conditions
- Keratitis, Corneal Ulcer
- Being tested
- Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution, Standard of Care Therapy + Sham CXL + Artificial Tears
- Medical subject headings
- Keratitis, Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Therapy + CXL + Riboflavin 0.23% L SolutionCombination product
Standard Of Care: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion. Following SOC, for subjects randomized to the experimental arm, riboflavin will be administered (1 drop every 2 min for 40 min with PESCHKE-L solution [0.23%], or longer as needed to assure adequate corneal penetration). Then the eye will be aligned under the PXL Platinum 330 light (the treatment plane will be at the correct working distance from the PXL Platinum 330 beam aperture when the border of the projected beam is in sharp focus). The correct aperture setting (3 to 12 mm) will be selected for the size of the eye and area needing to be treated (2 mm larger than the maximal ulcer diameter), and the eye will be irradiated at 18 mW/cm2, with pulsed mode (5 seconds on, 5 seconds off) for 10 min, during which time instillation of riboflavin will continue (1 drop every 2 min).
Standard of Care Therapy + Sham CXL + Artificial TearsOther
Standard Of Care: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion. Following SOC, for subjects randomized to the Sham comparator group, artificial tears (1 drop every 2 min for 40 min) will be administered. After instillation of artificial tears, the eye will be aligned under the PXL Platinum 330 light. The instrument will be kept off and the subject will be kept under the device for 10 min, during which time instillation of artificial tears will be performed (1 drop every 2 min) to maintain corneal hydration. The operator will keep track of sham exposure time independently to confirm the actual duration.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Therapy + Sham CXL + Artificial Tears | Sham comparator | Standard-of-care treatment and Sham CXL and administration of artificial tears. Receives: Other: Standard of Care Therapy + Sham CXL + Artificial Tears |
| Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution | Experimental | The PXL Platinum 330 Illumination System is a portable electronic medical device. The device's light emitting diode (LED) is used to deliver a metered dose of UV-A light to a targeted treatment area for illuminating the cornea during corneal collagen CXL. PESCHKE-L Solution is a riboflavin 5'-phosphate 0.23% ophthalmic solution that functions as a photosensitizer and is indicated for use with the PXL Platinum 330 Illumination System. Designed to be used when there is epithelial disruption as can occur with a corneal ulcer or wound. It does not contain benzalkonium chloride. It is intended to achieve rapid absorption. Receives: Combination Product: Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and effectiveness of corneal collagen CXL for treating previously untreated corneal ulcers
Primary Outcome Measure:
- The composite primary endpoint outcome would be the proportion of patients in the treated group, compared to the control group, who achieve all three of the following components:
- complete re-epithelialization at week 2, defined as absence of corneal fluorescein staining noted with the blue light of the slit lamp by the investigator.
- no expansion of infiltrate from baseline to week 2. The size of the infiltrate will be reviewed by the investigator using the slit lamp exam and compared to baseline measures to assess expansion of the infiltrate.
- a negative corneal culture at week 2
- Each of the components of this composite endpoints is a binary outcome (yes or no), and are NOT measured as units of measure.
Measured: Week 2 (#+/- 2 study days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start14 Mar 2022
- Primary completion24 Nov 2023 (estimated)
- Study completion24 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple block randomization will be used to assign subjects in a 1:1 ratio to 2 treatment arms. Subjects will be randomized consecutively (not stratified by site) to ensure balance between the treatment arms at any point in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peschke GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvette Viscuso, Study director, Peschke GmbHBala Ambati, Principal investigator, Pacific Clear Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255107
- Sponsor's protocol ID
- PXL-330-02B
- Status last verified
- Jul 2022
- First submitted
- 26 Jan 2022
- Last updated
- 28 Oct 2022
- 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 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Previously Untreated Corneal Ulcers
- ClinicalTrials.gov ID
- NCT05255107
- Acronym / sponsor ID
- PXL-330-02B
- Conditions
- Keratitis, Corneal Ulcer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Peschke GmbHIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 24 Nov 2023 (estimated)
- Study completion
- 24 Feb 2024 (estimated)
- First posted
- 24 Feb 2022 (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 study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal collagen crosslinking (CXL) for the treatment of previously untreated corneal ulcers. The PXL Platinum 330 System is a combination product consisting of an ultraviolet A (UV-A) 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Riboflavin 0.23% PESCHKE-L Solution) administered in conjunction with the UV-A light as a photosensitizer. The PXL Platinum 330 System is intended to induce corneal collagen CXL to improve the biomechanical properties of the cornea by strengthening the corneal tissue in the anterior stroma. Corneal collagen CXL is performed by pretreating the cornea with riboflavin ophthalmic solution beginning 40 min before UV-A light exposure to saturate the corneal tissue with the riboflavin photosensitizer. The cornea is then irradiated with UV-A light (365 nm) at an irradiance of 18 mW/cm2 (5 seconds on, 5 seconds off) for 10 min. Exposure of the cornea to this UV-A light regimen after topical administration of riboflavin ophthalmic solution has been shown to induce CXL of the corneal collagen fibrils, with a resultant increase in tensile strength and diameter of the collagen fibrils. Clinically, CXL has been shown to stabilize the corneal curvature in eyes with progressive keratoconus, with no significant change in the refractive index of the cornea. Numerous reports and a few clinical trials have also shown benefit in aiding resolution of infective corneal ulcers.
Detailed description
This is a prospective, 2-arm parallel-group, single-masked, randomized multicenter study to determine the safety and effectiveness of the PXL Platinum 330 System for performing CXL in eyes with previously untreated corneal ulcers. Subjects with documented infectious corneal ulcers that have not been treated (treatment na ve) will be evaluated initially for suitability as candidates for CXL. Subjects who are candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required study procedures that are not part of the investigator's routine examination. After completing screening procedures, the diagnosis for each eligible eye will be confirmed. Subjects will be randomized to 1 of 2 groups, both including standard of care (SOC) treatment:
- SOC: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion
- CXL + SOC: Moxifloxacin 0.5% eyedrop therapy + CXL
Eyes undergoing CXL will have topical anesthetic administered and then have topical riboflavin instilled onto the cornea every 2 min (or longer as needed to assure adequate corneal penetration), after which the cornea will be exposed to UV-A pulsed light 18 mW/cm2 for 10 min. Riboflavin instillation will continue every 2 min during CXL. The CXL procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UV-A light source and riboflavin solution). All use of the PXL Platinum 330 System will be in accordance with this protocol and the general instructions provided by the manufacturer (PESCHKE) in the PXL Platinum 330 Illumination System Operator's Manual. All subjects will be evaluated at Screening/Baseline, Day 0 (Randomization/Treatment), Day 1, Day 3 ( 1 day), Week 1 ( 2 days), Week 2 ( 2 days), and Week 4 ( 3 days) after treatment. Efficacy monitoring throughout the study will include observations at appropriate times for re-epithelialization, size of infection, and corneal culture results. Safety monitoring throughout the study will include observations at appropriate times for pain, IOP, BSCVA, corneal scar size, AEs, clinically significant findings on ophthalmic examination, dilated fundus examination, and slit lamp examination. After treatment, subjects will be followed at the treating physician's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Simple block randomization will be used to assign subjects in a 1:1 ratio to 2 treatment arms. Subjects will be randomized consecutively (not stratified by site) to ensure balance between the treatment arms at any point in the study.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Therapy + Sham CXL + Artificial Tears | Sham comparator | Other: Standard of Care Therapy + Sham CXL + Artificial TearsStandard-of-care treatment and Sham CXL and administration of artificial tears. |
| Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution | Experimental | Combination Product: Standard of Care Therapy + CXL + Riboflavin 0.23% L SolutionThe PXL Platinum 330 Illumination System is a portable electronic medical device. The device's light emitting diode (LED) is used to deliver a metered dose of UV-A light to a targeted treatment area for illuminating the cornea during corneal collagen CXL. PESCHKE-L Solution is a riboflavin 5'-phosphate 0.23% ophthalmic solution that functions as a photosensitizer and is indicated for use with the PXL Platinum 330 Illumination System. Designed to be used when there is epithelial disruption as can occur with a corneal ulcer or wound. It does not contain benzalkonium chloride. It is intended to achieve rapid absorption. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who have one or both eyes that meet the following criteria will be considered candidates for this study:
Key exclusion criteria (11 listed)
- All subjects meeting any of the following criteria will be excluded from this 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 |
|---|---|---|
| Standard of Care Therapy + CXL + Riboflavin 0.23% L SolutionStandard Of Care: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion. Following SOC, for subjects randomized to the experimental arm, riboflavin will be administered (1 drop every 2 min for 40 min with PESCHKE-L solution [0.23%], or longer as needed to assure adequate corneal penetration). Then the eye will be aligned under the PXL Platinum 330 light (the treatment plane will be at the correct working distance from the PXL Platinum 330 beam aperture when the border of the projected beam is in sharp focus). The correct aperture setting (3 to 12 mm) will be selected for the size of the eye and area needing to be treated (2 mm larger than the maximal ulcer diameter), and the eye will be irradiated at 18 mW/cm2, with pulsed mode (5 seconds on, 5 seconds off) for 10 min, during which time instillation of riboflavin will continue (1 drop every 2 min). | Combination product | Standard of Care Therapy + CXL + Riboflavin 0.23% L Solution |
| Standard of Care Therapy + Sham CXL + Artificial TearsStandard Of Care: Moxifloxacin 0.5% eyedrop therapy every 1 hour (q1h) while awake; to be tapered at treating physician's discretion. Following SOC, for subjects randomized to the Sham comparator group, artificial tears (1 drop every 2 min for 40 min) will be administered. After instillation of artificial tears, the eye will be aligned under the PXL Platinum 330 light. The instrument will be kept off and the subject will be kept under the device for 10 min, during which time instillation of artificial tears will be performed (1 drop every 2 min) to maintain corneal hydration. The operator will keep track of sham exposure time independently to confirm the actual duration. | Other | Standard of Care Therapy + Sham CXL + Artificial Tears |
Primary outcome
To evaluate the safety and effectiveness of corneal collagen CXL for treating previously untreated corneal ulcers
Time frame: Week 2 (#+/- 2 study days).
Primary Outcome Measure: 1. The composite primary endpoint outcome would be the proportion of patients in the treated group, compared to the control group, who achieve all three of the following components: * complete re-epithelialization at week 2, defined as absence of corneal fluorescein staining noted with the blue light of the slit lamp by the investigator. * no expansion of infiltrate from baseline to week 2. The size of the infiltrate will be reviewed by the investigator using the slit lamp exam and compared to baseline measures to assess expansion of the infiltrate. * a negative corneal culture at week 2 2. Each of the components of this composite endpoints is a binary outcome (yes or no), and are NOT measured as units of measure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Keratitis
RecruitingPhase 1/2
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
Neurotrophic Keratopathy
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 2
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
Fungal Keratitis
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
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.
Yvette Viscuso study director
Peschke GmbH
Bala Ambati principal investigator
Pacific Clear Vision Institute
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study of Keratitis and Corneal Ulcer, run by Peschke GmbH at 12 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 7 inclusion and 11 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Patricia Huezo-Diaz Curtis, PhD (0041 (0) 787 422151, Patricia.Huezo-Diaz@confinis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and effectiveness of corneal collagen CXL for treating previously untreated corneal ulcers (time frame: Week 2 (#+/- 2 study days).). 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 Oct 2022.