Official Title: “Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-Controlled Trial”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: neomycin sulfate, polymyxin B sulfate and gramicidin
  • to the effected eye 4 times a day
• Drug: Artificial tear
  • 4 times daily

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: B
  • Artificial tear containing antibiotic solution base
• Experimental: A
  • combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)

Primary Measures

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

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Chulalongkorn University

Overall Clinical Trial Officials and Contacts

Parima Hirunwiwatkul, MD Principal Investigator Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University  

Overall Contact: Parima Hirunwiwatkul, MD 662-2564142 parima.H@chula.ac.th

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00534391

Study ID Number: 59/50

ClinicalTrials.gov Identifier: NCT00534391

Health Authority: Thailand: Ethical Committee