Moxifloxacin vs. Polytrim for Conjunctivitis

Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581542
• Other study ID #: RSRB #17454
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2007
• Last updated: December 11, 2015
• Start date: March 2007
• Est. completion date: March 2012

Study information

• Verified date: December 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous antibiotics or to receive systemic antibiotic.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis

Intervention

Drug:
• moxifloxacin
1-2 drops three times a day for 8-10 days.
• polytrim
1-2 drops four times a day for 8-10 days.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Normal Physical Examination of the Eye		10 days	No
Secondary	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	No