Back to resultsComparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage
Primary Purpose
Hordeolum
Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
neomycin sulfate, polymyxin B sulfate and gramicidin
Artificial tear
Sponsored by
About this trial
This is an interventional treatment trial for Hordeolum focused on measuring Antibiotics, hordeolum
Eligibility Criteria
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
Sites / Locations
- Department of Ophthalmology, Chulalongkorn UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
B
A
Arm Description
Artificial tear containing antibiotic solution base
combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)
Outcomes
Primary Outcome Measures
Pain scale
Secondary Outcome Measures
Mass size and duration of cure
Full Information
NCT ID
NCT00534391
First Posted
September 21, 2007
Last Updated
November 22, 2010
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT00534391
Brief Title
Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage
Official Title
Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chulalongkorn University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hordeolum
Keywords
Antibiotics, hordeolum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Artificial tear containing antibiotic solution base
Arm Title
A
Arm Type
Experimental
Arm Description
combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)
Intervention Type
Drug
Intervention Name(s)
neomycin sulfate, polymyxin B sulfate and gramicidin
Other Intervention Name(s)
Neosporin, Polyoph
Intervention Description
to the effected eye 4 times a day
Intervention Type
Drug
Intervention Name(s)
Artificial tear
Other Intervention Name(s)
Tear natural II, Lacoph
Intervention Description
4 times daily
Primary Outcome Measure Information:
Title
Pain scale
Time Frame
1,3,7 days after treatment
Secondary Outcome Measure Information:
Title
Mass size and duration of cure
Time Frame
1, 3, 7, 30 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Parima Hirunwiwatkul, MD
Phone
662-2564142
Ext
205
Email
parima.H@chula.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Puangphet Chalermphanich, MD
Phone
662-2564142
Ext
207
Email
puangphet_c@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parima Hirunwiwatkul, MD
Organizational Affiliation
Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parima Hirunwiwatkul, MD
Phone
662-2564142
Ext
205
Email
parima.H@chula.ac.th
First Name & Middle Initial & Last Name & Degree
Puangphet Chalermphanich, MD
Phone
662-256-4142
Ext
207
Email
puangphet_c@yahoo.com
First Name & Middle Initial & Last Name & Degree
Parima Hirunwiwatkul, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16149682
Citation
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.
Results Reference
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Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage
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