NCT00972777

Brief Summary

This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
474

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

September 4, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 29, 2012

Completed
Last Updated

March 29, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

September 4, 2009

Results QC Date

January 12, 2012

Last Update Submit

February 14, 2012

Conditions

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (2)

  • Clinical Resolution

    The absence of both conjunctival discharge and bulbar conjunctival injection.

    Visit 2

  • Microbial Eradication

    The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.

    Visit 2

Secondary Outcomes (2)

  • Clinical Resolution

    Visit 3

  • Microbial Eradication

    Visit 3

Study Arms (2)

Besifloxacin

EXPERIMENTAL

0.6% ophthalmic suspension

Drug: Besifloxacin

Vehicle

PLACEBO COMPARATOR
Drug: Vehicle (Placebo)

Interventions

BesifloxacinDRUG

Besifloxacin 0.6% administered into the study eye two times a day for three days.

Also known as: Besivance
Besifloxacin
Vehicle (Placebo)DRUG

Vehicle administered to the study eye two times a day for three days.

Vehicle

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are at least one year of age.
  • Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
  • Subjects who are willing to discontinue contact lens wear for the duration of the study.

You may not qualify if:

  • Subjects who have any uncontrolled systemic disease or debilitating disease.
  • Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
  • Subjects who are expected to require treatment with any disallowed medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

Related Publications (3)

  • Haas W, Gearinger LS, Hesje CK, Sanfilippo CM, Morris TW. Microbiological etiology and susceptibility of bacterial conjunctivitis isolates from clinical trials with ophthalmic, twice-daily besifloxacin. Adv Ther. 2012 May;29(5):442-55. doi: 10.1007/s12325-012-0023-y. Epub 2012 May 25.

    PMID: 22644963DERIVED

  • DeLeon J, Silverstein BE, Allaire C, Gearinger LS, Bateman KM, Morris TW, Comstock TL. Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children. Clin Drug Investig. 2012 May 1;32(5):303-17. doi: 10.2165/11632470-000000000-00000.

    PMID: 22420526DERIVED

  • Silverstein BE, Allaire C, Bateman KM, Gearinger LS, Morris TW, Comstock TL. Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and children. Clin Ther. 2011 Jan;33(1):13-26. doi: 10.1016/j.clinthera.2010.12.004.

    PMID: 21397770DERIVED

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

besifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases

Results Point of Contact

Title
Tuyen Ong, MD, MRCOphth
Organization
Bausch & Lomb Incorporated
tuyen.ong@bausch.com
(973) 360-6389

Study Officials

  • Michael R Paterno, OD

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 9, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

February 1, 2011

Last Updated

March 29, 2012

Results First Posted

March 29, 2012

Record last verified: 2012-02

Locations

US(1)