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

NCT00534391 — Phase 3, Unknown, 120 participants, Chulalongkorn University

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

Registry	NCT00534391
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	120 (Estimated)
Sponsor	Chulalongkorn University (Other)
Conditions	Hordeolum
Interventions	neomycin sulfate, polymyxin B sulfate and gramicidin, Artificial tear (Drug)
Dates	start 2007-09-01, completion 2008-12-01 (estimated), first posted 2007-09-24, last updated 2010-11-23
Locations	1 site in Thailand

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
B	Placebo comparator	Drug: Artificial tear	Artificial tear containing antibiotic solution base
A	Experimental	Drug: neomycin sulfate, polymyxin B sulfate and gramicidin	combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)

neomycin sulfate, polymyxin B sulfate and gramicidin (Drug), also known as Neosporin, Polyoph: to the effected eye 4 times a day
Artificial tear (Drug), also known as Tear natural II, Lacoph: 4 times daily

+Outcome measures

Primary outcomes

Pain scale [1,3,7 days after treatment]

Secondary outcomes

Mass size and duration of cure [1, 3, 7, 30 days after treatment]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Department of Ophthalmology, Chulalongkorn University	Bangkok	Thailand	Recruiting

+Publications

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. PMID 16149682

+Investigators

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