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

NCT00534391 | Unknown Phase 3 DMC

• 1 other identifier: 59/50
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Hordeolum

Keywords

Antibiotics; hordeolum

Outcome Measures

Primary Outcomes (1)

• Pain scale

  1,3,7 days after treatment

Secondary Outcomes (1)

• Mass size and duration of cure

  1, 3, 7, 30 days after treatment

Study Arms (2)

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

neomycin sulfate, polymyxin B sulfate and gramicidin DRUG

to the effected eye 4 times a day

Also known as: Neosporin, Polyoph

A

Artificial tear DRUG

4 times daily

Also known as: Tear natural II, Lacoph

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 5-millimeters hordeolum
• the onset within 7 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Department of Ophthalmology, Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

Related Publications (1)

• 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.

  PMID: 16149682 BACKGROUND

MeSH Terms

Conditions

Hordeolum

Interventions

Neomycin; Polymyxin B; Gramicidin; bacitracin zinc, neomycin sulfate, polymyxin B, drug combination; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Tyrothricin; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Parima Hirunwiwatkul, MD

  Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parima Hirunwiwatkul, MD

CONTACT

662-2564142; parima.H@chula.ac.th

Puangphet Chalermphanich, MD

CONTACT

662-2564142; puangphet_c@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 24, 2007
• Study Start: September 1, 2007
• Study Completion: December 1, 2008
• Last Updated: November 23, 2010

Record last verified: 2010-11

Locations

TH (1)