Ultraviolet-A and Riboflavin Treatment for Infectious Ker... | NCT01739673

Studies
Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

NCT01739673

Sponsor

Cxlusa

Status

Completed

Last Update Posted

Sep 26, 2018Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

Infectious Keratitis

Interventions

Ultraviolet-A and riboflavin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Nov 27, 2012

First Submission Date that Met QC Criteria

Nov 30, 2012

First Posted Date

Dec 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2018

Last Update Posted Date

Sep 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultraviolet-A and riboflavin	Experimental		Other: Ultraviolet-A and riboflavin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultraviolet-A and riboflavin	Other		Ultraviolet-A and riboflavin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of Signs and Symptoms of Infectious Keratitis		Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Trattler, MD	Center For Excellence In Eye Care	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schwartz Laser Eye Center		Scottsdale	Arizona		United States
Davidorf Eye Group

Intervention Browse Module

MeSH Terms

ID	Term
D012256	Riboflavin

Ancestor Terms

ID	Term
D005415	Flavins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided