NCT00581542

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 18, 2016

Completed
Last Updated

January 18, 2016

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

December 18, 2007

Results QC Date

April 15, 2015

Last Update Submit

December 11, 2015

Conditions

Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Normal Physical Examination of the Eye

    10 days

Secondary Outcomes (1)

  • Number of Participants With a Negative Bacterial Culture

    10 days

Study Arms (2)

Moxifloxacin Opthalmic solution

ACTIVE COMPARATOR
Drug: polytrim

Polymyxin B-trimethoprim opthalmic solution

ACTIVE COMPARATOR
Drug: moxifloxacin

Interventions

moxifloxacinDRUG

1-2 drops three times a day for 8-10 days.

Polymyxin B-trimethoprim opthalmic solution
polytrimDRUG

1-2 drops four times a day for 8-10 days.

Moxifloxacin Opthalmic solution

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age with presumed bacterial conjunctivitis.

You may not qualify if:

  • Previous antibiotics or to receive systemic antibiotic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Conjunctivitis

Interventions

MoxifloxacinPolytrim eyedrops

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

No adverse events

Results Point of Contact

Title
Franci Gigilotti
Organization
University of Rochester, Strong Mem orial Hospital
francis_gigilotti@urmc.rochester.edu
585 275-0588

Study Officials

  • Francis Gigliotti, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 27, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2012

Last Updated

January 18, 2016

Results First Posted

January 18, 2016

Record last verified: 2015-12

Locations

US(1)