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

Chulalongkorn University

Status and phase: Unknown; Phase 3

Conditions: Hordeolum

Treatments: Drug: Artificial tear; Drug: neomycin sulfate, polymyxin B sulfate and gramicidin

Study type: Interventional

Funder types: Other

Identifiers

NCT00534391

59/50

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

B

Placebo Comparator group

Description:

Artificial tear containing antibiotic solution base

Treatment:

Drug: Artificial tear

A

Experimental group

Description:

combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)

Treatment:

Drug: neomycin sulfate, polymyxin B sulfate and gramicidin