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Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00622908
First Posted: February 25, 2008
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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) ]
    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) ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622908


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

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
First Submitted: February 14, 2008
First Posted: February 25, 2008
Results First Submitted: June 29, 2009
Results First Posted: August 13, 2009
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection