NCT01330355

Brief Summary

The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 3, 2014

Completed
Last Updated

September 3, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

April 5, 2011

Results QC Date

August 21, 2014

Last Update Submit

September 2, 2014

Conditions

Bacterial Conjunctivitis

Keywords

Ocular infections, bacterial

Outcome Measures

Primary Outcomes (1)

  • Clinical Resolution

    Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.

    Visit 5 (Day 8+1)

Secondary Outcomes (3)

  • Clinical Resolution

    Visit 3 (Day 3)

  • Microbial Eradication

    Visit 5 (Day 8+1)

  • Microbial Outcome

    Visit 3 (Day 3) and Visit 5 (Day 8+1)

Study Arms (2)

Besivance

EXPERIMENTAL

Besifloxacin 0.6% ophthalmic suspension

Drug: Besivance

Gatifloxacin

ACTIVE COMPARATOR

Gatifloxacin 0.3% ophthalmic solution

Drug: Gatifloxacin

Interventions

BesivanceDRUG

Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Besivance
GatifloxacinDRUG

Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Gatifloxacin

Eligibility Criteria

Age1 Day - 31 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.

You may not qualify if:

  • Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.
  • Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.
  • Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
  • Subjects with systemic disease/disorder specified in the protocol as ineligible.
  • Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.
  • Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb Incorporated

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Conjunctivitis, BacterialEye Infections, Bacterial

Interventions

besifloxacinGatifloxacin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Johnson Varughese
Organization
Valeant Pharmaceuticals
Johnson.Varughese@valeant.com
908-541-2179

Study Officials

  • Johnson Varughese

    Valeant/Bausch & Lomb

    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
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 6, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

October 1, 2013

Last Updated

September 3, 2014

Results First Posted

September 3, 2014

Record last verified: 2014-08

Locations

US(1)