Comparison of Combination Antibiotics Eyedrop to Artifici... | NCT00534391

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

NCT00534391

Sponsor

Chulalongkorn University

Status

Unknown status

Last Update Posted

Nov 23, 2010Estimated

Enrollment

120Estimated

Phase

Phase 3

Conditions

Hordeolum

Interventions

neomycin sulfate, polymyxin B sulfate and gramicidin
Artificial tear

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Sep 21, 2007

First Submission Date that Met QC Criteria

Sep 21, 2007

First Posted Date

Sep 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2010

Last Update Posted Date

Nov 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Placebo Comparator	Artificial tear containing antibiotic solution base	Drug: Artificial tear
A	Experimental	combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)	Drug: neomycin sulfate, polymyxin B sulfate and gramicidin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neomycin sulfate, polymyxin B sulfate and gramicidin	Drug	to the effected eye 4 times a day	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain scale		1,3,7 days after treatment

Secondary Outcomes

Measure	Description	Time Frame
Mass size and duration of cure		1, 3, 7, 30 days after treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Parima Hirunwiwatkul, MD	Contact	662-2564142	205	parima.H@chula.ac.th
Puangphet Chalermphanich, MD	Contact	662-2564142	207	puangphet_c@yahoo.com

Overall Officials

Name	Affiliation	Role
Parima Hirunwiwatkul, MD	Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Chulalongkorn University	Recruiting	Bangkok		10330	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16149682	Background	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.

ID	Term
D015818	Eye Infections, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D009355	Neomycin
D011112	Polymyxin B
D006096	Gramicidin
C001816	bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
D065346	Lubricant Eye Drops

ID	Term
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D011113	Polymyxins