Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
Condition: Ocular Infections, Irritations and Inflammations
MeSH terms: Eye Infections; Inflammation
Intervention: KPI-121 0.25%; KPI-121 1.0%; Vehicle of KPI-121 0.25%; Vehicle of KPI-121 1.0%
Intervention description: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.; KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.; Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.; Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 380.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: postsurgical; postoperative; ocular; cataract; inflammation; pain; corticosteroid

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121
      ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
      The efficacy and safety of two different concentrations and two different dosing regimens of
      KPI-121 are also being assessed.
    

Eligibility criteria:

        FURTHER STUDY DETAILS PROVIDED BY KALA PHARMACEUTICALS, INC.

        Inclusion Criteria:

          -  Candidates for routine, uncomplicated cataract surgery

          -  In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole
             method of at least 20/200 in study eye.

        Exclusion Criteria:

          -  Known hypersensitivity/contraindication to study product(s) or components.

          -  History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being
             treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of
             Investigator could confound study assessments or limit compliance; or have been
             exposed to an investigational drug within the 30 days prior to screening or 19 days
             following surgery.

          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply
             with study protocol or unable to successfully instill eye drops.