Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage

This study is currently recruiting participants.

Verified by Chulalongkorn University, September 2007

First Received: September 21, 2007 No Changes Posted

Sponsor:	Chulalongkorn University
Information provided by:	Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00534391

Purpose

To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of hordeolum after incision and curettage

Condition	Intervention	Phase
Hordeolum	Drug: neomycin sulfate, polymyxin B sulfate and gramicidin Drug: Artificial tear	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Neomycin palmitate Gramicidin S Neomycin Polymyxin B Neomycin sulfate Polymyxin B Sulfate Gramicidin

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

Pain scale [ Time Frame: 1,3,7 days after treatment ]

Secondary Outcome Measures:

Mass size and duration of cure [ Time Frame: 1, 3, 7, 30 days after treatment ]

Estimated Enrollment:	120
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
B: Placebo Comparator Artificial tear containing antibiotic solution base	Drug: Artificial tear 4 times daily
A: Experimental combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)	Drug: neomycin sulfate, polymyxin B sulfate and gramicidin to the effected eye 4 times a day

Detailed Description:

Hordeolum is a common eyelid disease. In case of mass, I&C is required but role of antibiotic after I&C is not clear. It may not need in post drainage period.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

at least 5-millimeters hordeolum
the onset within 7 days

Exclusion Criteria:

previous incision and curettage of the same site within 1 month or more than 3 times
lesions in the adjacent areas suggesting of complications associated with hordeolum such as preseptal cellulitis or blepharitis
The patients with immunodeficiency, history of bleeding tendency
allergy to aminoglycoside, polymyxin B, gramicidin, xylocaine and povidone iodine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534391

Contacts

Contact: Parima Hirunwiwatkul, MD	662-2564142 ext 205	parima.H@chula.ac.th
Contact: Puangphet Chalermphanich, MD	662-2564142 ext 207	puangphet_c@yahoo.com

Locations

Thailand
Department of Ophthalmology, Chulalongkorn University	Recruiting
Bangkok, Thailand, 10330
Contact: Parima Hirunwiwatkul, MD 662-2564142 ext 205 parima.H@chula.ac.th
Contact: Puangphet Chalermphanich, MD 662-256-4142 ext 207 puangphet_c@yahoo.com
Principal Investigator: Parima Hirunwiwatkul, MD

Sponsors and Collaborators

Chulalongkorn University

Investigators

Principal Investigator:

Parima Hirunwiwatkul, MD

Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

More Information

Publications:

Hirunwiwatkul P, Wachirasereechai K. Effectiveness of combined antibiotic ophthalmic solution in the treatment of hordeolum after incision and curettage: a randomized, placebo-controlled trial: a pilot study. J Med Assoc Thai. 2005 May;88(5):647-50.

Study ID Numbers:	59/50
Study First Received:	September 21, 2007
Last Updated:	September 21, 2007
ClinicalTrials.gov Identifier:	NCT00534391 History of Changes
Health Authority:	Thailand: Ethical Committee; Thailand: Food and Drug Administration

Keywords provided by Chulalongkorn University:

Antibiotics
hordeolum

Additional relevant MeSH terms:

Bacterial Infections
Eye Infections, Bacterial
Anti-Infective Agents
Gramicidin
Molecular Mechanisms of Pharmacological Action
Polymyxin B
Eye Diseases
Eye Infections
Enzyme Inhibitors

Infection
Hordeolum
Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Infective Agents, Local
Anti-Bacterial Agents
Therapeutic Uses
Eyelid Diseases
Neomycin

ClinicalTrials.gov processed this record on February 08, 2010