Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Moxifloxacin vs. Polytrim for Conjunctivitis

This study has been completed.
Information provided by (Responsible Party):
Frank Gigliotti, University of Rochester Identifier:
First received: December 18, 2007
Last updated: December 11, 2015
Last verified: December 2015
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 Intervention Phase
Drug: moxifloxacin
Drug: polytrim
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Single Blinded Clinical Trial Comparing Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution for Treatment of Conjunctivitis.

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Number of Participants With Normal Physical Examination of the Eye [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With a Negative Bacterial Culture [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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.

Enrollment: 124
Study Start Date: March 2007
Study Completion Date: March 2012
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous antibiotics or to receive systemic antibiotic.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00581542

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Francis Gigliotti, MD University of Rochester
  More Information

Responsible Party: Frank Gigliotti, Professor, University of Rochester Identifier: NCT00581542     History of Changes
Other Study ID Numbers: RSRB #17454 
Study First Received: December 18, 2007
Results First Received: April 15, 2015
Last Updated: December 11, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
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 processed this record on October 21, 2016