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

Phase 3

• Conditions: Hordeolum
• Interventions: Drug: neomycin sulfate, polymyxin B sulfate and gramicidin; Drug: Artificial tear

• Registration Number: NCT00534391
• Lead Sponsor: Chulalongkorn University

Brief 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

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-21
• Study First Posted: 2007-09-24
• Study Completion: 2008-12
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-22
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	neomycin sulfate, polymyxin B sulfate and gramicidin	combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)
B	Artificial tear	Artificial tear containing antibiotic solution base

Primary Outcome Measures

Name	Time	Method
Pain scale	1,3,7 days after treatment

Secondary Outcome Measures

Name	Time	Method
Mass size and duration of cure	1, 3, 7, 30 days after treatment

Trial Locations

Locations (1)

Department of Ophthalmology, Chulalongkorn University; 🇹🇭 Bangkok, Thailand