2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery
Condition: Inflammation and Pain Associated With Cataract Surgery
MeSH terms: Cataract; Inflammation
Intervention: ISV-305; Vehicle
Intervention description: Dexamethasone in DuraSite® 2 twice daily for 16 days; Vehicle twice daily for 16 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 246.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of
      ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation
      and pain associated with cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are at least 17 years of age

          -  Are scheduled for uncomplicated unilateral cataract surgery

          -  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

          -  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 any sign of iritis or scleritis in the study eye

          -  Have an acute ocular infection (bacterial, viral or fungal) or active ocular
             inflammation in the study eye

          -  Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled
             and likely to affect wound healing (e.g., diabetes mellitus, systemic connective
             tissue disease, severe atopic disease)

          -  Have known blood dyscrasia or bone marrow suppression

          -  Have any active corneal pathology in the study eye

          -  Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the
             last 2 years

          -  Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine
             pregnancy test

          -  Have prior (within 30 days of beginning study treatment) 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

          -  Use of any medication the investigator feels may interfere with the study parameters

          -  Additional exclusion criteria also apply