Bacterial KeratitisCXLNCT02088970
Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study. (CXL)
A study testing Crosslinking and antibiotic treatment in people with Bacterial Keratitis and Fungal Keratitis, run by Nantes University Hospital at 1 site in France.
Trial summary
The corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Keratitis, Fungal Keratitis
- What is being tested?
- Crosslinking and antibiotic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Apr 2017
- 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
- Infectious bacterial or fungal keratitis with : size > 2mm or within the central corneal area ( 3mm of the visual axis ) or with a reaction in anterior chamber.
- Being major responsible.
- Agreement in writing to participate in the study.
- Being affiliated to a national insurance scheme.
Who cannot join
- Present an infectious keratitis without all the previous criteria.
- Herpes or acanthamoeba keratitis
- preperforated or perforated cornea.
- General criteria:
- Pregnant woman.
- Minors(miners).
Show all 11Show fewer
- Adults under guardianship.
- Patient can not be followed during 3 necessary months.
- French speaking patient.
- Unaffiliated patient in a national insurance scheme.
- HIV infected patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.
The corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing of the cornea.
- Conditions
- Bacterial Keratitis, Fungal Keratitis
- Being tested
- Crosslinking, antibiotic treatment
- Keywords
- Infectious keratitis, Corneal cross linking, Topical antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrosslinkingDevice
Also called Riboflavine 0,1%., Ricrolin., CE 0037., médical device class IIb.
The procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea.
Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation.
antibiotic treatmentDrug
If not the contact lens wearer -> Cocci Gram positive cocci
- Vancomycin + Fortum
If contact lens wearer -> Gram negative bacillus
- Fortum + Amiklin
If corticosteroids, immunosuppression, latent evolution -> Fungus.
= Fortum + vancomycin + Fungizone
| Study group | Role | What they receive |
|---|---|---|
| antibiotic treatment alone | Active comparator | Not described Receives: Drug: antibiotic treatment |
| Crosslinking + Antibiotic | Experimental | The procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea.
Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation. Receives: Device: Crosslinking; Drug: antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of corneal complete epithelial healing in days.
Measured: 3 months
Secondary outcomes (3)
Size of the corneal scar
Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.
Measured: 3months
Corneal thinning
Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.
Measured: 3 months
Gain of visual acuity
Gain of visual acuity, corresponding to the difference between the initial visual acuity and the 3months one. The visual acuity is measured with monoyer scale and converted in log Mar.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Difficulties in reaching the desired number of patients and intermediate analysis leading to discontinuation of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial KeratitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088970
- Sponsor's protocol ID
- RC14_0004
- Acronym
- CXL
- Status last verified
- May 2017
- First submitted
- 13 Mar 2014
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
PubMed 32557558
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.
- ClinicalTrials.gov ID
- NCT02088970
- Acronym / sponsor ID
- CXL / RC14_0004
- Conditions
- Bacterial Keratitis, Fungal Keratitis
- Keywords
- Infectious keratitis, Corneal cross linking, Topical antibiotics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in reaching the desired number of patients and intermediate analysis leading to discontinuation of the study.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Mar 2014 (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 corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing of the cornea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibiotic treatment alone | Active comparator | Drug: antibiotic treatment |
| Crosslinking + Antibiotic | Experimental | Device: Crosslinking, Drug: antibiotic treatmentThe procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea. Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Infectious bacterial or fungal keratitis with : size > 2mm or within the central corneal area ( 3mm of the visual axis ) or with a reaction in anterior chamber.
- Being major responsible.
- Agreement in writing to participate in the study.
- Being affiliated to a national insurance scheme.
Key exclusion criteria (11 listed)
- Present an infectious keratitis without all the previous criteria.
- Herpes or acanthamoeba keratitis
- preperforated or perforated cornea.
- Pregnant woman.
- Minors(miners).
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 |
|---|---|---|
| CrosslinkingAlso: Riboflavine 0,1%., Ricrolin., CE 0037., médical device class IIb.The procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea. Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation. | Device | Crosslinking + Antibiotic |
| antibiotic treatmentIf not the contact lens wearer -> Cocci Gram positive cocci * Vancomycin + Fortum If contact lens wearer -> Gram negative bacillus * Fortum + Amiklin If corticosteroids, immunosuppression, latent evolution -> Fungus. = Fortum + vancomycin + Fungizone | Drug | Crosslinking + Antibiotic, antibiotic treatment alone |
Primary outcome
Duration of corneal complete epithelial healing in days.
Time frame: 3 months
3 secondary outcomes
Size of the corneal scar
Time frame: 3months
Corneal thinning
Time frame: 3 months
Gain of visual acuity
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Difficulties in reaching the desired number of patients and intermediate analysis leading to discontinuation of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Derived from this study: PubMed 32557558Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crosslinking and antibiotic treatment in people with Bacterial Keratitis and Fungal Keratitis, run by Nantes University Hospital at 1 site in France.
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 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: stopped early, as of the sponsor's last update on 1 Jun 2017. 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 France. 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 was stopped early (reason given: Difficulties in reaching the desired number of patients and intermediate analysis leading to discontinuation of the study.). Results are not available in the source record.
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?
Duration of corneal complete epithelial healing in days. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02088970, which also lists 1 linked publication.
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 1 Jun 2017.