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

NCT ID: NCT00534391

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Hordeolum

Keywords

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Antibiotics hordeolum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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B

Artificial tear containing antibiotic solution base

Group Type PLACEBO_COMPARATOR

Artificial tear

Intervention Type DRUG

4 times daily

A

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

Group Type EXPERIMENTAL

neomycin sulfate, polymyxin B sulfate and gramicidin

Intervention Type DRUG

to the effected eye 4 times a day

Interventions

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neomycin sulfate, polymyxin B sulfate and gramicidin

to the effected eye 4 times a day

Intervention Type DRUG

Artificial tear

4 times daily

Intervention Type DRUG

Other Intervention Names

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Neosporin Polyoph Tear natural II Lacoph

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Chulalongkorn University

Principal Investigators

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Parima Hirunwiwatkul, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

Locations

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Department of Ophthalmology, Chulalongkorn University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Parima Hirunwiwatkul, MD

Role: CONTACT

Phone: 662-2564142

Email: [email protected]

Puangphet Chalermphanich, MD

Role: CONTACT

Phone: 662-2564142

Email: [email protected]

Facility Contacts

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Parima Hirunwiwatkul, MD

Role: primary

Puangphet Chalermphanich, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 16149682 (View on PubMed)

Other Identifiers

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59/50

Identifier Type: -

Identifier Source: org_study_id