Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00622908
First received: February 14, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of bacterial conjunctivitis


Condition Intervention Phase
Bacterial Conjunctivitis
Drug: ISV-403
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) [ Time Frame: Visit 3 - day 8 or 9 ] [ Designated as safety issue: No ]
    Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

  • Eradication of Baseline Pathogens (Day 8 or 9) [ Time Frame: Visit 3 - Day 8 or day 9 ] [ Designated as safety issue: No ]
    Bacterial species eradication of baseline bacterial infection


Secondary Outcome Measures:
  • Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day) [ Time Frame: Visit 2 - Day 4 (+/- 1 day) ] [ Designated as safety issue: No ]
    The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

  • Eradication of Baseline Pathogens Day 4 (+/- 1 Day) [ Time Frame: Visit 2 - Day 4 (+/- 1 day) ] [ Designated as safety issue: No ]
    Bacterial species eradication of baseline bacterial infection


Enrollment: 270
Study Start Date: December 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISV-403
ISV-403 0.6%
Drug: ISV-403
0.6% TID, 5 days
Other Name: besifloxacin
Placebo Comparator: Vehicle
Vehicle of ISV-403
Drug: Vehicle
Vehicle of ISV-403 TID, 5 days

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least one year of age.
  • Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form.
  • Must have signature of subject on the Assent Form if subject is 6 to 17 years of age.
  • 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. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection.
  • Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria.
  • Must be willing to discontinue contact lens wear for the duration of the study.
  • Must be willing to avoid disallowed medications during the study period.
  • Must understand the scope of the study including completion of diary, be willing to follow instructions, and be able to make all required study visits.
  • If a subject was a female of childbearing potential, she must utilize reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria:

  • Any uncontrolled systemic disease or debilitating disease.
  • Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study.
  • Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study.
  • Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media.
  • Pregnant or nursing females.
  • Known hypersensitivity to SS734 or to any of the ingredients in the study medications.
  • Known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medications.
  • Ocular surgery (including laser surgery) in either eye within the past six weeks.
  • Subjects with suspected viral or allergic conjunctivitis (i.e., severe itching or acute follicular conjunctivitis), or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
  • Subjects with suspected iritis (i.e., smaller pupil, pain, and photophobia in infected eye).
  • History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
  • Use of any antibiotic within 72 hours of enrollment.
  • Any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis
  • Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study.
  • Subjects who were immune compromised.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00622908

Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Timothy Comstock, OD Bausch & Lomb Incorporated
  More Information

No publications provided by Bausch & Lomb Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00622908     History of Changes
Other Study ID Numbers: 373
Study First Received: February 14, 2008
Results First Received: June 29, 2009
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Besifloxacin
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014