NCT00347932

Brief Summary

Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
957

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2006

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, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 13, 2009

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

1.4 years

First QC Date

June 30, 2006

Results QC Date

June 29, 2009

Last Update Submit

March 4, 2015

Conditions

Acute Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (2)

  • Clinical Resolution of Baseline Bacterial Conjunctivitis

    The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection

    Day 5 +/- 1 day

  • Microbial Eradication of Baseline Bacterial Infection

    Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.

    Day 5 +/- 1 day

Secondary Outcomes (2)

  • Clinical Resolution of Baseline Bacterial Conjunctivitis

    Day 8 or 9

  • Microbial Eradication of Baseline Bacterial Infection

    Day 8 or 9

Study Arms (2)

ISV-403

EXPERIMENTAL

0.6% ISV-403 ophthalmic suspension

Drug: ISV-403

Vehicle

PLACEBO COMPARATOR

Vehicle of ISV-403 ophthalmic suspension

Drug: Vehicle

Interventions

ISV-403DRUG

Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.

Also known as: besifloxacin, Besivance, BOL-303224
ISV-403
VehicleDRUG

Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.

Vehicle

Eligibility Criteria

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

You may qualify if:

  • Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
  • Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

You may not qualify if:

  • Pregnant or nursing females.
  • Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
  • Use of any antibiotic within 72 hours of treatment.
  • Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
  • Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.

    PMID: 32841261DERIVED

  • Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.

    PMID: 20629472DERIVED

  • Tepedino ME, Heller WH, Usner DW, Brunner LS, Morris TW, Haas W, Paterno MR, Comstock TL. Phase III efficacy and safety study of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis. Curr Med Res Opin. 2009 May;25(5):1159-69. doi: 10.1185/03007990902837919.

    PMID: 19323612DERIVED

MeSH Terms

Interventions

besifloxacin

Results Point of Contact

Title
Timothy Comstock
Organization
Bausch & Lomb Incorporated
timothy.comstock@bausch.com
(585) 338-6631

Study Officials

  • Laura Trusso

    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

June 30, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

March 24, 2015

Results First Posted

August 13, 2009

Record last verified: 2015-03