Infectious KeratitisNCT01739673
Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis
A study testing Ultraviolet-A and riboflavin in people with Infectious Keratitis, run by Cxlusa at 6 sites in United States.
Trial summary
This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Keratitis
- What is being tested?
- Ultraviolet-A and riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2011to Jul 2014
- Phase
- Interventional
- 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 must be 18 years of age or older.
- Ability to provide written informed consent.
- Likely to complete all study visits.
- Subjects must have one eye that with a diagnosis of infectious keratitis.
Who cannot join
- A corneal perforation.
- Descemetocele.
- Pregnancy or breastfeeding.
- Active Herpes corneal disease.
- Patient is unwilling or unable to comply with a medication regimen and follow up appointments.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Corneal Consultants of Colorado, PC
Littleton, Colorado
Center for Excellence in Eye Care
Miami, Florida
Minnesota Eye Consultants
Minneapolis, Minnesota
Schwartz Laser Eye Center
Scottsdale, Arizona
Ophthalmology Associates
St Louis, Missouri
Davidorf Eye Group
West Hills, California
About this study
This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.
- Conditions
- Infectious Keratitis
- Being tested
- Ultraviolet-A and riboflavin
- Keywords
- Infectious Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraviolet-A and riboflavinOther
| Study group | Role | What they receive |
|---|---|---|
| Ultraviolet-A and riboflavin | Experimental | Not described Receives: Other: Ultraviolet-A and riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Signs and Symptoms of Infectious Keratitis
Measured: Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startAug 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cxlusa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Trattler, MD, Study director, Center For Excellence In Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739673
- Sponsor's protocol ID
- iCXL
- Status last verified
- Aug 2015
- First submitted
- 27 Nov 2012
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis
- ClinicalTrials.gov ID
- NCT01739673
- Acronym / sponsor ID
- iCXL
- Conditions
- Infectious Keratitis
- Keywords
- Infectious Keratitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- CxlusaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Dec 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.
This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultraviolet-A and riboflavin | Experimental | Other: Ultraviolet-A and riboflavin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be 18 years of age or older.
- Ability to provide written informed consent.
- Likely to complete all study visits.
- Subjects must have one eye that with a diagnosis of infectious keratitis.
Key exclusion criteria (5 listed)
- A corneal perforation.
- Descemetocele.
- Pregnancy or breastfeeding.
- Active Herpes corneal disease.
- Patient is unwilling or unable to comply with a medication regimen and follow up appointments.
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 |
|---|---|---|
| Ultraviolet-A and riboflavin | Other | Ultraviolet-A and riboflavin |
Primary outcome
Resolution of Signs and Symptoms of Infectious Keratitis
Time frame: Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
Related trials for Infectious Keratitis
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Active, not recruitingPhase 3
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
Bacterial Keratitis
Not yet recruitingPhase 3
RB-PDT for Fusarium Keratitis: The LUMIERE Study
Fusarium Keratitis
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
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.
William Trattler, MD study director
Center For Excellence In Eye Care
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraviolet-A and riboflavin in people with Infectious Keratitis, run by Cxlusa at 6 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resolution of Signs and Symptoms of Infectious Keratitis (time frame: Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks). 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 Sep 2018.