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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Chulalongkorn University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00534391
First received: September 21, 2007
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mass size and duration of cure [ Time Frame: 1, 3, 7, 30 days after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
Placebo Comparator: B
Artificial tear containing antibiotic solution base
 Drug: Artificial tear
4 times daily
Other Names:
  • Tear natural II
  • Lacoph
Experimental: A
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
Other Names:
  • Neosporin
  • Polyoph

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:

Responsible Party: Department of Opthalmology, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00534391     History of Changes
Other Study ID Numbers: 59/50
Study First Received: September 21, 2007
Last Updated: November 22, 2010
Health Authority: Thailand: Ethical Committee
Thailand: Food and Drug Administration

Keywords provided by Chulalongkorn University:
Antibiotics
hordeolum

Additional relevant MeSH terms:
Hordeolum
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Eye Diseases
Eyelid Diseases
Polymyxin B
Anti-Bacterial Agents
Gramicidin
 Neomycin
Polymyxins
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013