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

Hordeolum Clinical Trial

Official title:

Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00534391
• Other study ID #: 59/50
• Status: Recruiting
• Phase: Phase 3
• First received: September 21, 2007
• Last updated: November 22, 2010
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2010
• Source: Chulalongkorn University
• Contact: Parima Hirunwiwatkul, MD
• Phone: 662-2564142
• Email: parima.H[@]chula.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical CommitteeThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hordeolum

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Ophthalmology, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scale		1,3,7 days after treatment	Yes
Secondary	Mass size and duration of cure		1, 3, 7, 30 days after treatment	Yes