Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
Condition: Active, Symptomatic Blepharitis
MeSH terms: Blepharitis
Intervention: ISV-305; Vehicle
Intervention description: Dexamethasone in DuraSite® 2 twice daily for 2 weeks; Vehicle twice daily for 2 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 558.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305
      (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active,
      symptomatic Blepharitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are at least 1 years of age and have a clinical diagnosis of active, symptomatic
             blepharitis

          -  Signature of the subject or parent(s) or legally authorized representative on the
             Informed Consent Form, and when appropriate the minor's assent in accordance with
             local regulations

          -  Are willing and able to follow all instructions and attend all study visits (this
             applies to parent or caregiver for subjects too young to self-apply investigational
             product)

          -  Are willing to avoid disallowed medication for the duration of the study

          -  If female is of childbearing potential, agree to and submit a urine sample for
             pregnancy testing (prior to enrollment and at the end of the study) and use effective
             contraception for the duration of the study

          -  Male subjects whose female partners are not post-menopausal must agree to one of the
             following: 1) completely abstain from sexual intercourse, 2) use a barrier method
             (condoms) with spermicide during sexual intercourse for the duration of the study, 3)
             provide documentation for having had a vasectomy (with documented infertility)

          -  Additional inclusion criteria also apply

        Exclusion Criteria:

          -  Have known sensitivity or poor tolerance to any component of the study drugs

          -  Have had eyelid surgery in the study eye within twelve (12) months prior to Visit 1 or
             plan to have eyelid surgery during the study

          -  Have an acute ocular infection (bacterial, viral or fungal) or active ocular
             inflammation other than blepharitis in the study eye

          -  Have used topical medications on the eyelids or topical ophthalmic corticosteroid
             medications or systemic use of a corticosteroid mediation within 14 days prior to
             dosing and/or plan to use them throughout the duration of the study

          -  Be currently pregnant, nursing, or planning a pregnancy; or be a woman who has a
             positive urine pregnancy test

          -  Have prior (within 30 days prior to dosing) or anticipated concurrent use of an
             investigational drug or device

          -  Have a condition or a situation which, in the investigator's opinion, may put the
             subject at increased risk, confound study data, or interfere significantly with the
             subject's study participation

          -  Additional exclusion criteria also apply