Moxifloxacin vs. Polytrim for Conjunctivitis

A Single Blinded Clinical Trial Comparing Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution for Treatment of Conjunctivitis.

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.

Study Overview

• Status: Completed
• Conditions: Conjunctivitis
• Intervention / Treatment: Drug: polytrim; Drug: moxifloxacin

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Previous antibiotics or to receive systemic antibiotic.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Normal Physical Examination of the Eye	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 days

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Francis Gigliotti, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: December 11, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: RSRB #17454