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Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

Primary Purpose

Bacterial Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ISV-403
Vehicle
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ISV-403

    Vehicle

    Arm Description

    ISV-403 0.6%

    Vehicle of ISV-403

    Outcomes

    Primary Outcome Measures

    Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
    Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
    Eradication of Baseline Pathogens (Day 8 or 9)
    Bacterial species eradication of baseline bacterial infection

    Secondary Outcome Measures

    Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
    The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
    Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
    Bacterial species eradication of baseline bacterial infection

    Full Information

    First Posted
    February 14, 2008
    Last Updated
    March 4, 2015
    Sponsor
    Bausch & Lomb Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00622908
    Brief Title
    Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    June 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch & Lomb Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Conjunctivitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    270 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ISV-403
    Arm Type
    Experimental
    Arm Description
    ISV-403 0.6%
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    Vehicle of ISV-403
    Intervention Type
    Drug
    Intervention Name(s)
    ISV-403
    Other Intervention Name(s)
    besifloxacin
    Intervention Description
    0.6% TID, 5 days
    Intervention Type
    Drug
    Intervention Name(s)
    Vehicle
    Intervention Description
    Vehicle of ISV-403 TID, 5 days
    Primary Outcome Measure Information:
    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
    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
    Secondary Outcome Measure Information:
    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)
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Timothy Comstock, OD
    Organizational Affiliation
    Bausch & Lomb Incorporated
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32841261
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    20629472
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    19393842
    Citation
    Karpecki P, Depaolis M, Hunter JA, White EM, Rigel L, Brunner LS, Usner DW, Paterno MR, Comstock TL. Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study. Clin Ther. 2009 Mar;31(3):514-26. doi: 10.1016/j.clinthera.2009.03.010.
    Results Reference
    derived

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    Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

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