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Moxifloxacin vs. Polytrim for Conjunctivitis

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ClinicalTrials.gov Identifier: NCT00581542
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Frank Gigliotti, University of Rochester

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study will investigate if both of the medications are equally good.

Condition or disease Intervention/treatment Phase
Conjunctivitis Drug: moxifloxacin Drug: polytrim Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Single Blinded Clinical Trial Comparing Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution for Treatment of Conjunctivitis.
Study Start Date : March 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Moxifloxacin Opthalmic solution Drug: polytrim
1-2 drops four times a day for 8-10 days.
Active Comparator: Polymyxin B-trimethoprim opthalmic solution Drug: moxifloxacin
1-2 drops three times a day for 8-10 days.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants With Normal Physical Examination of the Eye [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Number of Participants With a Negative Bacterial Culture [ Time Frame: 10 days ]
    Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified.


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1 - 18 years of age with presumed bacterial conjunctivitis.

Exclusion Criteria:

  • Previous antibiotics or to receive systemic antibiotic.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00581542


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Francis Gigliotti, MD University of Rochester
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Frank Gigliotti, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00581542     History of Changes
Other Study ID Numbers: RSRB #17454
First Posted: December 27, 2007    Key Record Dates
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors