TreatmentNCT03138785
UVX as an Adjuvant in the Treatment of Fungal Keratitis
A study testing topical voriconazole / levofloxacin systemic itraconazole and CXL in people with Treatment, run by Farabi Eye Hospital.
Trial summary
In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Treatment
- What is being tested?
- topical voriconazole / levofloxacin systemic itraconazole and CXL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- fungal keratitis documented by culture or confocal scanning without any previous treatment
Who cannot join
- Previous treatment
- Thinning at presentation
- Perforation
- Associated with other microbial or viral keratitis
About this study
In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis
- Conditions
- Treatment
- Being tested
- topical voriconazole / levofloxacin systemic itraconazole, CXL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical voriconazole / levofloxacin systemic itraconazoleDrug
starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks
CXLRadiation
Also called Collagen cross-linking/ UVx
30 min Riboflavin prescription to the cornea followed by 30 min UV-A radiation at 3mW/cm2 associated with Riboflavin administration
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment | Experimental | In this arm, patients with documented fungal keratitis undergo conventional medical treatment. Receives: Drug: topical voriconazole / levofloxacin systemic itraconazole |
| conventional treatment +CXL | Active comparator | In this arm, patients with documented fungal keratitis undergo conventional medical treatment plus CXL, beginning on the first day Receives: Drug: topical voriconazole / levofloxacin systemic itraconazole; Radiation: CXL |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of complete healing (days)
time to scar formation (days)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 Jan 2015
- Primary completion1 Jun 2017 (estimated)
- Study completion1 Jul 2017 (estimated)
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 TreatmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farabi Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammad soleimani, Farabi Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138785
- Sponsor's protocol ID
- 32768
- Status last verified
- Apr 2017
- First submitted
- 22 Feb 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UVX as an Adjuvant in the Treatment of Fungal Keratitis
- ClinicalTrials.gov ID
- NCT03138785
- Acronym / sponsor ID
- 32768
- Conditions
- Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Farabi Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2017 (estimated)
- Study completion
- 1 Jul 2017 (estimated)
- First posted
- 3 May 2017 (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.
In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Experimental | Drug: topical voriconazole / levofloxacin systemic itraconazoleIn this arm, patients with documented fungal keratitis undergo conventional medical treatment. |
| conventional treatment +CXL | Active comparator | Drug: topical voriconazole / levofloxacin systemic itraconazole, Radiation: CXLIn this arm, patients with documented fungal keratitis undergo conventional medical treatment plus CXL, beginning on the first day |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- fungal keratitis documented by culture or confocal scanning without any previous treatment
Key exclusion criteria (4 listed)
- Previous treatment
- Thinning at presentation
- Perforation
- Associated with other microbial or viral keratitis
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 |
|---|---|---|
| topical voriconazole / levofloxacin systemic itraconazolestarting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks | Drug | conventional treatment, conventional treatment +CXL |
| CXLAlso: Collagen cross-linking/ UVx30 min Riboflavin prescription to the cornea followed by 30 min UV-A radiation at 3mW/cm2 associated with Riboflavin administration | Radiation | conventional treatment +CXL |
Primary outcome
time of complete healing (days)
Time frame: 180 days
time to scar formation (days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing topical voriconazole / levofloxacin systemic itraconazole and CXL in people with Treatment, run by Farabi Eye Hospital.
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 1 inclusion and 4 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 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
time of complete healing (days) (time frame: 180 days). 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 NCT03138785, 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 3 May 2017.