NCT01478256

Brief Summary

This study looks at the improvements in signs and symptoms in patients with inflammation of the lids, blepharitis, using two different FDA approved topical antibiotic agents, Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for microbiologic evidence of improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2011

Shorter than P25 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

August 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 20, 2013

Completed
Last Updated

December 19, 2013

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

November 21, 2011

Results QC Date

April 9, 2013

Last Update Submit

November 20, 2013

Conditions

Blepharitis

Keywords

blepharitistopical erythromycintopical besifloxocin

Outcome Measures

Primary Outcomes (1)

  • Improvement in Signs and Symptoms of Blepharitis

    Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics

    Four weeks

Secondary Outcomes (1)

  • Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics

    Three weeks

Study Arms (2)

Besifloxocin

ACTIVE COMPARATOR

Use of topical besifloxocin to treat acute blepharitis

Drug: Besifloxocin

Erythromycin

ACTIVE COMPARATOR

Topical Erythromycin ointment for treatment of acute blepharitis

Drug: Erythromycin

Interventions

ErythromycinDRUG

Topical erythromycin ointment twice a day

Erythromycin
BesifloxocinDRUG

Topical Besifloxocin twice a day

Also known as: Besivance
Besifloxocin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George John, M.D.

Louisville, Kentucky, 40205, United States

Location

MeSH Terms

Conditions

Blepharitis

Interventions

Erythromycinbesifloxacin

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
George John
Organization
George John MD
grjohn777@yahoo.com
5028949757

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 19, 2013

Results First Posted

November 20, 2013

Record last verified: 2013-11

Locations

US(1)