NCT03138785

Brief Summary

In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

February 22, 2017

Last Update Submit

April 29, 2017

Conditions

Treatment

Outcome Measures

Primary Outcomes (1)

  • time of complete healing (days)

    time to scar formation (days)

    180 days

Study Arms (2)

conventional treatment

EXPERIMENTAL

In this arm, patients with documented fungal keratitis undergo conventional medical treatment.

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

Drug: topical voriconazole / levofloxacin systemic itraconazoleRadiation: CXL

Interventions

topical voriconazole / levofloxacin systemic itraconazoleDRUG

starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks

conventional treatmentconventional treatment +CXL
CXLRADIATION

30 min Riboflavin prescription to the cornea followed by 30 min UV-A radiation at 3mW/cm2 associated with Riboflavin administration

Also known as: Collagen cross-linking/ UVx
conventional treatment +CXL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • fungal keratitis documented by culture or confocal scanning without any previous treatment

You may not qualify if:

  • Previous treatment
  • Thinning at presentation
  • Perforation
  • Associated with other microbial or viral keratitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32557558DERIVED

MeSH Terms

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 22, 2017

First Posted

May 3, 2017

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-04