Back to resultsMoxifloxacin vs. Polytrim for Conjunctivitis
Primary Purpose
Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
moxifloxacin
polytrim
Sponsored by
About this trial
This is an interventional treatment trial for Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- 1 - 18 years of age with presumed bacterial conjunctivitis.
Exclusion Criteria:
- Previous antibiotics or to receive systemic antibiotic.
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Moxifloxacin Opthalmic solution
Polymyxin B-trimethoprim opthalmic solution
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Normal Physical Examination of the Eye
Secondary Outcome Measures
Number of Participants With a Negative Bacterial Culture
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.
Full Information
NCT ID
NCT00581542
First Posted
December 18, 2007
Last Updated
December 11, 2015
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT00581542
Brief Title
Moxifloxacin vs. Polytrim for Conjunctivitis
Official Title
A Single Blinded Clinical Trial Comparing Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution for Treatment of Conjunctivitis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxifloxacin Opthalmic solution
Arm Type
Active Comparator
Arm Title
Polymyxin B-trimethoprim opthalmic solution
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
moxifloxacin
Intervention Description
1-2 drops three times a day for 8-10 days.
Intervention Type
Drug
Intervention Name(s)
polytrim
Intervention Description
1-2 drops four times a day for 8-10 days.
Primary Outcome Measure Information:
Title
Number of Participants With Normal Physical Examination of the Eye
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Number of Participants With a Negative Bacterial Culture
Description
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.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1 - 18 years of age with presumed bacterial conjunctivitis.
Exclusion Criteria:
Previous antibiotics or to receive systemic antibiotic.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Gigliotti, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Moxifloxacin vs. Polytrim for Conjunctivitis
We'll reach out to this number within 24 hrs