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

November 22, 2010 updated by: Chulalongkorn University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Department of Ophthalmology, Chulalongkorn University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Parima Hirunwiwatkul, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Parima Hirunwiwatkul, MD, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion

December 8, 2022

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

September 21, 2007

First Submitted That Met QC Criteria

September 21, 2007

First Posted (Estimate)

September 24, 2007

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59/50

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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