Collagen Cross-linking in Infectious Keratitis Trial

Bacterial Keratitis Clinical Trial

Official title:

Collagen Cross-linking in Infectious Keratitis Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831206
• Other study ID #: 438/55
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2013
• Last updated: May 1, 2015
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Research Institute for Health Sciences
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Keratitis
• Communicable Diseases
• Fungal Keratitis
• Infection
• Infectious Keratitis
• Keratitis

Intervention

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.

Locations

Country	Name	City	State
Thailand	Ophthalmology department, King Chulalongkorn Memorial hospital	Pratumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrement of infiltration size	decrement of infiltration size between day0 and day 30	1 months	No
Secondary	number of participants with adverse events	adverse events after corneal collagen cross-linking (report in descriptive study)	1 months	Yes