Moxifloxacin vs. Polytrim for Conjunctivitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Rochester.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Rochester
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00581542
First received: December 18, 2007
Last updated: August 11, 2011
Last verified: August 2011
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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 Intervention Model: Single Group 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:
- Clinical Cure [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Microbiological cure [ Time Frame: 10 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: moxifloxacin
1-2 drops three times a day for 8-10 days.
|
| Active Comparator: 2 |
Drug: polytrim
1-2 drops four times a day for 8-10 days.
|
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| 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
Contacts
| Contact: Francis Gigliotti, MD | 585-275-5944 | Francis_gigliotti@urmc.rochester.edu | |
| Contact: Barbra L Murante, RN | 585-275-1549 | Barbra_murante@urmc.rochester.edu |
Locations
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
Sponsors and Collaborators
University of Rochester
Investigators
| Principal Investigator: | Francis Gigliotti, MD | University of Rochester |
More Information
No publications provided
| Responsible Party: | Francis Gigliotti, MD, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00581542 History of Changes |
| Other Study ID Numbers: | RSRB #17454 |
| Study First Received: | December 18, 2007 |
| Last Updated: | August 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctival Diseases Eye Diseases Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Bacterial Agents Anti-Infective Agents Antineoplastic Agents Contraceptive Agents Contraceptive Agents, Female |
Contraceptives, Oral Contraceptives, Oral, Combined Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015