NCT01739673

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 26, 2018

Status Verified

August 1, 2015

Enrollment Period

2.9 years

First QC Date

November 27, 2012

Last Update Submit

September 24, 2018

Conditions

Infectious Keratitis

Keywords

Infectious Keratitis

Outcome Measures

Primary Outcomes (1)

  • Resolution of Signs and Symptoms of Infectious Keratitis

    Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks

Study Arms (1)

Ultraviolet-A and riboflavin

EXPERIMENTAL
Other: Ultraviolet-A and riboflavin

Interventions

Ultraviolet-A and riboflavinOTHER
Ultraviolet-A and riboflavin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Location

Davidorf Eye Group

West Hills, California, United States

Location

Corneal Consultants of Colorado, PC

Littleton, Colorado, United States

Location

Center for Excellence in Eye Care

Miami, Florida, United States

Location

Minnesota Eye Consultants

Minneapolis, Minnesota, United States

Location

Ophthalmology Associates

St Louis, Missouri, United States

Location

MeSH Terms

Interventions

Riboflavin

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological Factors

Study Officials

  • William Trattler, MD

    Center For Excellence In Eye Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 3, 2012

Study Start

August 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 26, 2018

Record last verified: 2015-08

Locations

US(6)