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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. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Chulalongkorn University.
Recruitment status was:  Recruiting
Information provided by:
Chulalongkorn University Identifier:
First received: September 21, 2007
Last updated: November 22, 2010
Last verified: November 2010
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
Drug: neomycin sulfate, polymyxin B sulfate and gramicidin
Drug: Artificial tear
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00534391

Department of Ophthalmology, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Principal Investigator: Parima Hirunwiwatkul, MD Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University
  More Information

Responsible Party: Department of Opthalmology, Faculty of Medicine, Chulalongkorn University Identifier: NCT00534391     History of Changes
Other Study ID Numbers: 59/50 
Study First Received: September 21, 2007
Last Updated: November 22, 2010

Keywords provided by Chulalongkorn University:

Additional relevant MeSH terms:
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Eye Diseases
Eyelid Diseases
Anti-Bacterial Agents
Polymyxin B
Antibiotics, Antitubercular
Lubricant Eye Drops
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Infective Agents, Local processed this record on February 17, 2017