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Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00622908
Collaborator
(none)
270
Enrollment
2
Arms
6
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
270 participants
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
Study Start Date :
Dec 1, 2004
Actual Primary Completion Date :
Jun 1, 2005
Actual Study Completion Date :
Jun 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: ISV-403

ISV-403 0.6%

Drug: ISV-403
0.6% TID, 5 days
Other Names:
  • besifloxacin

    		•
    Placebo Comparator: Vehicle

    Vehicle of ISV-403

    Drug: Vehicle
    Vehicle of ISV-403 TID, 5 days

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) [Visit 3 - day 8 or 9]

      Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

    2. Eradication of Baseline Pathogens (Day 8 or 9) [Visit 3 - Day 8 or day 9]

      Bacterial species eradication of baseline bacterial infection

    Secondary Outcome Measures

    1. Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day) [Visit 2 - Day 4 (+/- 1 day)]

      The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

    2. Eradication of Baseline Pathogens Day 4 (+/- 1 Day) [Visit 2 - Day 4 (+/- 1 day)]

      Bacterial species eradication of baseline bacterial infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

    • Study Director: Timothy Comstock, OD, Bausch & Lomb Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT00622908
    Other Study ID Numbers:
    • 373
    First Posted:
    Feb 25, 2008
    Last Update Posted:
    Mar 24, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Conjunctivitis, Bacterial
    Conjunctivitis
    Besifloxacin

    Study Results

    Participant Flow

    Recruitment Details Study was started on 12/28/04 and last patient last visit was 6/7/05. This study took place at 35 centers in the US.
    Pre-assignment Detail 270 subjects were enrolled, 269 were randomized(1 subject refused culture), 118 of which had bacteriologically confirmed acute bacterial conjunctivitis at baseline.
    Arm/Group Title ISV-403 Vehicle
    Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403
    Period Title: Overall Study
    STARTED 137 132
    COMPLETED 134 122
    NOT COMPLETED 3 10

    Baseline Characteristics

    Arm/Group Title ISV-403 Vehicle Total
    Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403 Total of all reporting groups
    Overall Participants 137 132 269
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    33.3
    (22.3)
    35.1
    (22.4)
    34.2
    (22.3)
    Age, Customized (Number) [Number]
    < 2 years
    2
    1.5%
    1
    0.8%
    3
    1.1%
    2 to 19 Years
    44
    32.1%
    37
    28%
    81
    30.1%
    20 to 59 Years
    71
    51.8%
    71
    53.8%
    142
    52.8%
    >/=60 Years
    20
    14.6%
    23
    17.4%
    43
    16%
    Sex: Female, Male (Count of Participants)
    Female
    86
    62.8%
    76
    57.6%
    162
    60.2%
    Male
    51
    37.2%
    56
    42.4%
    107
    39.8%
    Race/Ethnicity, Customized (participants) [Number]
    Caucasian
    116
    84.7%
    106
    80.3%
    222
    82.5%
    Asian
    2
    1.5%
    2
    1.5%
    4
    1.5%
    Black or African American
    6
    4.4%
    11
    8.3%
    17
    6.3%
    Hispanic
    12
    8.8%
    8
    6.1%
    20
    7.4%
    Other
    1
    0.7%
    5
    3.8%
    6
    2.2%

    Outcome Measures

    1. Primary Outcome
    Title Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
    Description Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
    Time Frame Visit 3 - day 8 or 9

    Outcome Measure Data

    Analysis Population Description
    Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
    Arm/Group Title ISV-403 Vehicle
    Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403
    Measure Participants 60 56
    Number [Participants]
    37
    27%
    20
    15.2%
    2. Primary Outcome
    Title Eradication of Baseline Pathogens (Day 8 or 9)
    Description Bacterial species eradication of baseline bacterial infection
    Time Frame Visit 3 - Day 8 or day 9

    Outcome Measure Data

    Analysis Population Description
    Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
    Arm/Group Title ISV-403 Vehicle
    Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403
    Measure Participants 60 55
    Number [Participants]
    54
    39.4%
    38
    28.8%
    3. Secondary Outcome
    Title Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
    Description The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
    Time Frame Visit 2 - Day 4 (+/- 1 day)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
    Arm/Group Title ISV-403 Vehicle
    Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403
    Measure Participants 60 56
    Number [Participants]
    14
    10.2%
    8
    6.1%
    4. Secondary Outcome
    Title Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
    Description Bacterial species eradication of baseline bacterial infection
    Time Frame Visit 2 - Day 4 (+/- 1 day)

    Outcome Measure Data

    Analysis Population Description
    Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
    Arm/Group Title ISV-403 Vehicle
    Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403
    Measure Participants 60 54
    Number [Participants]
    54
    39.4%
    28
    21.2%

    Adverse Events

    Time Frame Treated period was 5 days
    Adverse Event Reporting Description
    Arm/Group Title ISV-403 Vehicle
    Arm/Group Description 0.6% ISV-403 Vehicle of ISV-403
    All Cause Mortality
    ISV-403 Vehicle
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    ISV-403 Vehicle
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/137 (0.7%) 1/132 (0.8%)
    Nervous system disorders
    Loss of Consciousness 1/137 (0.7%) 1 1/132 (0.8%) 1
    Other (Not Including Serious) Adverse Events
    ISV-403 Vehicle
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 45/137 (32.8%) 46/132 (34.8%)
    Eye disorders
    Eye Pain 16/137 (11.7%) 24 8/132 (6.1%) 24
    Blurred Vision 15/137 (10.9%) 28 13/132 (9.8%) 28
    Eye Irritation 11/137 (8%) 27 16/132 (12.1%) 27
    Eye Pruritis 3/137 (2.2%) 12 9/132 (6.8%) 12

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Sponsor has 45 days to review materials and provide comments back to the investigator.

    Results Point of Contact

    Name/Title Timothy Comstock
    Organization Bausch & Lomb Incorporated
    Phone (585) 338-6631
    Email timothy.comstock@bausch.com
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT00622908
    Other Study ID Numbers:
    • 373
    First Posted:
    Feb 25, 2008
    Last Update Posted:
    Mar 24, 2015
    Last Verified:
    Mar 1, 2015