Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain

The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.

Study Overview

• Status: Completed
• Conditions: Post Surgical Ocular Inflammation and Pain
• Intervention / Treatment: Drug: KPI-121 1% Ophthalmic Suspension dosed BID; Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID

Detailed Description

This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Arizona Eye Center
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of CA
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology
    • Glendale, California, United States, 91204
      • Lugene Eye Institute
    • Hemet, California, United States, 92545
      • Inland Eye Specialists
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center
    • Oceanside, California, United States, 92056
      • Pendleton Eye Center
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.
    • Poway, California, United States, 92064
      • Arch Health Partners
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
    • Redding, California, United States, 96002
      • Shasta Eye Medical Group, Inc
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Eye Center of Northern Colorado, PC
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates
    • Largo, Florida, United States, 33773
      • Shettle Eye Research, Inc
    • Tampa, Florida, United States, 33603
      • International Research Center
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Chicago Cornea Consultants, Ltd.
    • Lake Villa, Illinois, United States, 60046
      • Jacksoneye, S. C.
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Great Lakes Eye Care
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Minnesota Eye Consultants, PA
  • Missouri
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Abrams Eye Institute
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke University Eye Center
  • Ohio
    • Cincinnati, Ohio, United States, 45247
      • Apex Eye
  • Oregon
    • Roseburg, Oregon, United States, 97471
      • Roseburg Research Associates, LLC
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Carolina Cataract & Laser Center
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina EyeCare Physicians, LLC
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye, PA / Keystone Research, Ltd
    • El Paso, Texas, United States, 79902
      • The Cataract & Glaucoma Center
    • Houston, Texas, United States, 77024
      • Houston Eye Associates
    • San Antonio, Texas, United States, 78213
      • Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, intraocular pressure (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 18 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: KPI-121 1.0% Ophthalmic Suspension; dosed BID	Drug: KPI-121 1% Ophthalmic Suspension dosed BID; Other Names: Loteprednol etabonate
Placebo Comparator: Vehicle of KPI-121 Ophthalmic Suspension; dosed BID	Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Resolution of Anterior Chamber (AC) Cells at Day 8	Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen; = 1 - 5 cells; = 6 - 15 cells; = 16 - 30 cells; = greater than 30 cells	Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Complete Resolution of Ocular Pain at Day 8	Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None; = Minimal; = Mild; = Moderate; = Moderately Severe; = Severe	Visit 5 (Day 8) maintained through Visit 6 (Day 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Resolution of Ocular Pain at Day 4	Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None; = Minimal; = Mild; = Moderate; = Moderately Severe; = Severe	Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Complete Resolution of Anterior Chamber (AC) Flare at Day 4	Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better. Anterior Chamber Flare 0 = None; = Mild (trace to clearly noticeable, visible); = Moderate (without plastic aqueous humor); = Marked (with plastic aqueous humor); = Severe (with fibrin deposits and/or clots)	Visit 4 (Day 4) maintained through Visit 6 (Day 15)
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4	The difference in mean changes from BL in AC cell count grade at Day 4 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen; = 1 - 5 cells; = 6 - 15 cells; = 16 - 30 cells; = greater than 30 cells	Visit 1 (Baseline) and Visit 4 (Day 4)

Collaborators and Investigators

• Sponsor: Kala Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: pain; inflammation; cataract; corticosteroid; postoperative; ocular; postsurgical
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: KPI-121-C-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No