NCT01175590

Brief Summary

The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
518

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 1, 2013

Completed
Last Updated

May 1, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

August 3, 2010

Results QC Date

February 13, 2013

Last Update Submit

March 19, 2013

Conditions

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (2)

  • Ocular Treatment Emergent Adverse Events

    Ocular Treatment-Emergent Adverse Events on the Study Eye

    At each visit - 7 days

  • Non-Ocular Treatment-Emergent Adverse Events

    Non-Ocular Treatment-Emergent Adverse Events on the Study Eye

    7 days

Secondary Outcomes (12)

  • Clinical Resolution

    Day 8 (Visit 2)

  • Clinical Resolution

    Day 11 (Visit 3)

  • Microbial Eradication

    Days 8 (Visit 2)

  • Microbial Eradication

    Days 11 (Visit 3)

  • Microbial Outcome With Clinical Resolution

    Day 8 (Visit 2)

  • +7 more secondary outcomes

Study Arms (2)

Besivance

EXPERIMENTAL

besifloxacin ophthalmic suspension 0.6%

Drug: Besivance

Vehicle

PLACEBO COMPARATOR

Vehicle of Besivance

Drug: Vehicle

Interventions

BesivanceDRUG

Ocular administration to affected eye for 7 days

Besivance
VehicleDRUG

Vehicle of Besivance administered to affected eye for 7 days

Vehicle

Eligibility Criteria

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

You may qualify if:

  • Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye.
  • Subjects who are willing to discontinue contact lens wear for the duration of the study.
  • Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

You may not qualify if:

  • Subjects who have any uncontrolled systemic disease or debilitating disease.
  • Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs.
  • Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy)
  • Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
  • Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
  • Subjects with suspected iritis.
  • Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
  • Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
  • Subjects who are immune compromised.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb, Inc.

Rochester, New York, 14609, United States

Location

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 Inc.
tuyen.ong@bausch.com
(973) 360-6389

Study Officials

  • Catherine Allaire, MD

    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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 5, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

May 1, 2013

Results First Posted

May 1, 2013

Record last verified: 2013-03

Locations

US(1)