NCT00912509

Brief Summary

This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 22, 2014

Completed
Last Updated

November 22, 2017

Status Verified

October 1, 2017

Enrollment Period

4.1 years

First QC Date

May 30, 2009

Results QC Date

August 4, 2014

Last Update Submit

October 19, 2017

Conditions

Infectious Keratitis

Keywords

infectious keratitiscross linkingcorneal ulcercorneal infectioncollagen cross linking

Outcome Measures

Primary Outcomes (1)

  • Time to Re-epithelialization

    Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete

Secondary Outcomes (1)

  • Time to Resolution of Stromal Infiltration

    day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved

Study Arms (2)

30 minute light duration

ACTIVE COMPARATOR

30 minute treatment with UVX light

Drug: riboflavinDevice: UVX Light

45 minute light duration

ACTIVE COMPARATOR

45 minute treatment with UVX light

Device: UVX Light

Interventions

riboflavinDRUG

riboflavin 0.1% is applied every 2 minutes for 30 minutes

30 minute light duration
UVX LightDEVICE

UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

30 minute light duration45 minute light duration

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of infectious keratitis

You may not qualify if:

  • corneal ulcer that has perforated
  • corneal ulcer that has produced a descemetocele
  • women who are pregnant or breastfeeding
  • patients who are immunocompromised or unwilling or unable to comply with a medication regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Related Publications (3)

  • Iseli HP, Thiel MA, Hafezi F, Kampmeier J, Seiler T. Ultraviolet A/riboflavin corneal cross-linking for infectious keratitis associated with corneal melts. Cornea. 2008 Jun;27(5):590-4. doi: 10.1097/ICO.0b013e318169d698.

    PMID: 18520510BACKGROUND

  • Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06.

    PMID: 23062001RESULT

  • 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

Related Links

MeSH Terms

Conditions

Corneal Ulcer

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Marianne O. Price, PhD
Organization
Cornea Research Foundation of America
mprice@cornea.org
317-814-2990

Study Officials

  • Francis W Price, MD

    Price Vision Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2009

First Posted

June 3, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 22, 2017

Results First Posted

August 22, 2014

Record last verified: 2017-10

Locations

US(1)