Collagen Cross-linking in Infectious Keratitis Trial

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01831206
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infectious Keratitis; Bacterial Keratitis; Fungal Keratitis	Procedure: Collagen cross-linking	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Collagen Cross-linking in Infectious Keratitis Trial
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. decrement of infiltration size [1 months]

   decrement of infiltration size between day0 and day 30

Secondary Outcome Measures

1. number of participants with adverse events [1 months]

   adverse events after corneal collagen cross-linking (report in descriptive study)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology department, King Chulalongkorn Memorial hospital	Pratumwan	Bangkok	Thailand	10330

Sponsors and Collaborators

• Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ngamjit Kasetsuwan, Associated professor, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT01831206
• Other Study ID Numbers: 438/55
• First Posted: Apr 15, 2013
• Last Update Posted: May 4, 2015
• Last Verified: Apr 1, 2013

• Keywords provided by Ngamjit Kasetsuwan, Associated professor, Chulalongkorn University: corneal ulcer; keratitis
• Additional relevant MeSH terms: Communicable Diseases; Infections; Keratitis

Study Results

No Results Posted as of May 4, 2015