Moxifloxacin vs. Polytrim for Conjunctivitis
This study has been completed.
Sponsor:
University of Rochester
Information provided by (Responsible Party):
Frank Gigliotti, University of Rochester
ClinicalTrials.gov Identifier:
NCT00581542
First received: December 18, 2007
Last updated: December 11, 2015
Last verified: December 2015
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Purpose
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 |
|---|---|---|
|
Conjunctivitis |
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.
|
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| 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
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 ClinicalTrials.gov identifier: NCT00581542
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Frank Gigliotti, Professor, University of Rochester |
| ClinicalTrials.gov 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:
|
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 |
ClinicalTrials.gov processed this record on September 28, 2016