KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children

Overview

This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.

Full Title of Study: “Safety and Efficacy of KPI-121 1% Ophthalmic Suspension Versus Prednisolone Acetate Ophthalmic Suspension 1% for the Treatment of Inflammation Following Cataract Surgery in Children 0 to 3 Years of Age”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 28, 2018

Interventions

  • Drug: KPI-121 1%
    • eye drops
  • Drug: Prednisolone acetate
    • eye drops

Arms, Groups and Cohorts

  • Experimental: KPI-121 1% BID (twice daily)
  • Active Comparator: Prednisolone acetate QID (four times daily)

Clinical Trial Outcome Measures

Primary Measures

  • Anterior Chamber Cell Grade
    • Time Frame: Day 15
    • Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (> 30 cells) as follows: Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 – 5 cells Anterior chamber cell grade 2 = 6 – 15 cells Anterior chamber cell grade 4 = greater than 30 cells

Secondary Measures

  • Modified Global Overall Assessment of Postoperative Inflammation
    • Time Frame: Day 15
    • The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. Lower values indicate greater healing.The Modified Global Assessment grading uses whole numbers from 0 (clear) to 2 (not improving or worsening) as follows: 0 = clear = improving satisfactorily = not improving or worsening

Participating in This Clinical Trial

Inclusion Criteria

  • Be a candidate for routine, uncomplicated cataract surgery Exclusion Criteria:

  • Have a post-traumatic cataract. – Have suspected permanent low vision or blindness in the fellow non-study eye. – Have active uveitis in either eye. – Have an ocular neoplasm in either eye. – Have the presence of viral, bacterial, or fungal disease in either eye. – Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or elevated IOP

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 3 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kala Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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