Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: ISV-403; Vehicle
Intervention description: 0.6% TID, 5 days; Vehicle of ISV-403 TID, 5 days
Intervention MeSH terms: Besifloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 270.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

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
    

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.