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Sponsored by: |
Chulalongkorn University |
---|---|
Information provided by: | Chulalongkorn University |
ClinicalTrials.gov Identifier: | NCT00534391 |
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 | Intervention | Phase |
---|---|---|
Hordeolum |
Drug: neomycin sulfate, polymyxin B sulfate and gramicidin Drug: Artificial tear |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Dose Antibiotic Need in Hordeolum After Incision and Curettage? : A Randomized, Placebo-Controlled Trial |
Estimated Enrollment: | 120 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
---|---|
B: Placebo Comparator
Artificial tear containing antibiotic solution base
|
Drug: Artificial tear
4 times daily
|
A: Experimental
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Parima Hirunwiwatkul, MD | Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University |
Study ID Numbers: | 59/50 |
Study First Received: | September 21, 2007 |
Last Updated: | September 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00534391 History of Changes |
Health Authority: | Thailand: Ethical Committee; Thailand: Food and Drug Administration |
Antibiotics hordeolum |
Lacerations Bacterial Infections Eye Infections, Bacterial Gramicidin Polymyxin B Eye Diseases Eye Infections |
Tetrahydrozoline Hordeolum Anti-Bacterial Agents Anti-Infective Agents, Local Polymyxins Neomycin |
Bacterial Infections Eye Infections, Bacterial Anti-Infective Agents Gramicidin Molecular Mechanisms of Pharmacological Action Polymyxin B Eye Diseases Eye Infections Enzyme Inhibitors |
Infection Hordeolum Pharmacologic Actions Protein Synthesis Inhibitors Anti-Infective Agents, Local Anti-Bacterial Agents Therapeutic Uses Eyelid Diseases Neomycin |