Collagen Cross-linking in Infectious Keratitis Trial

May 1, 2015 updated by: Ngamjit Kasetsuwan, Chulalongkorn University
The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Pratumwan, Bangkok, Thailand, 10330
        • Ophthalmology department, King Chulalongkorn Memorial hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collagen cross-linking
Collagen cross-linking with standard treatment
Procedure: Collagen cross-linking

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.
No Intervention: standard treatment
Standard treatment alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
decrement of infiltration size
Time Frame: 1 months
decrement of infiltration size between day0 and day 30
1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with adverse events
Time Frame: 1 months
adverse events after corneal collagen cross-linking (report in descriptive study)
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 6, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 438/55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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