NCT01831206

Brief Summary

The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

April 6, 2013

Last Update Submit

May 1, 2015

Conditions

Infectious KeratitisBacterial KeratitisFungal Keratitis

Keywords

corneal ulcerkeratitis

Outcome Measures

Primary Outcomes (1)

  • decrement of infiltration size

    decrement of infiltration size between day0 and day 30

    1 months

Secondary Outcomes (1)

  • number of participants with adverse events

    1 months

Study Arms (2)

Collagen cross-linking

EXPERIMENTAL

Collagen cross-linking with standard treatment

Procedure: Collagen cross-linking

standard treatment

NO INTERVENTION

Standard treatment alone

Interventions

Collagen cross-linkingPROCEDURE

Collagen cross-linking arm will receive standard medication for corneal ulcer treatment and corneal collagen cross-linking. Standard treatment arm will receive only standard medication.

Collagen cross-linking

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal)
  • Age more than 6 year
  • Patients can understand and can follow the study protocol

You may not qualify if:

  • Pregnancy by history or urine test
  • Evidence of herpetic keratitis
  • Evidence of corneal perforation
  • Evidence of autoimmune disease
  • Known allergy to study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology department, King Chulalongkorn Memorial hospital

Pratumwan, Bangkok, 10330, Thailand

Location

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

Conditions

Corneal UlcerKeratitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsCorneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

April 6, 2013

First Posted

April 15, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

December 1, 2014

Last Updated

May 4, 2015

Record last verified: 2013-04

Locations

TH(1)