We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00534391
Recruitment Status : Unknown
Verified November 2010 by Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : September 24, 2007
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
Chulalongkorn University

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

Condition or disease Intervention/treatment Phase
Hordeolum Drug: neomycin sulfate, polymyxin B sulfate and gramicidin Drug: Artificial tear Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-controlled Trial
Study Start Date : September 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Tears
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: B
Artificial tear containing antibiotic solution base
Drug: Artificial tear
4 times daily
Other Names:
  • Tear natural II
  • Lacoph
Experimental: A
combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin)
Drug: neomycin sulfate, polymyxin B sulfate and gramicidin
to the effected eye 4 times a day
Other Names:
  • Neosporin
  • Polyoph



Primary Outcome Measures :
  1. Pain scale [ Time Frame: 1,3,7 days after treatment ]

Secondary Outcome Measures :
  1. Mass size and duration of cure [ Time Frame: 1, 3, 7, 30 days after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534391


Contacts
Contact: Parima Hirunwiwatkul, MD 662-2564142 ext 205 parima.H@chula.ac.th
Contact: Puangphet Chalermphanich, MD 662-2564142 ext 207 puangphet_c@yahoo.com

Locations
Thailand
Department of Ophthalmology, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Parima Hirunwiwatkul, MD    662-2564142 ext 205    parima.H@chula.ac.th   
Contact: Puangphet Chalermphanich, MD    662-256-4142 ext 207    puangphet_c@yahoo.com   
Principal Investigator: Parima Hirunwiwatkul, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Parima Hirunwiwatkul, MD Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

Publications:
Responsible Party: Department of Opthalmology, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00534391     History of Changes
Other Study ID Numbers: 59/50
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 2010

Keywords provided by Chulalongkorn University:
Antibiotics
hordeolum

Additional relevant MeSH terms:
Hordeolum
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Eye Diseases
Eyelid Diseases
Anti-Bacterial Agents
Polymyxins
Polymyxin B
Neomycin
Gramicidin
Antibiotics, Antitubercular
Lubricant Eye Drops
Anti-Infective Agents
Antitubercular Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local