Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease (STRIDE 2)

A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Intervention / Treatment: Drug: KPI-121 0.25% Ophthalmic Suspension; Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension

Detailed Description

This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

• Study Type: Interventional
• Enrollment (Actual): 909
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0010
      • UAB School of Optometry
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Arizona Eye Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Azusa, California, United States, 91702
      • Milton M. Hom, OD, FAAO
    • Campbell, California, United States, 95008
      • Family Eye Care Center
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology
    • Glendale, California, United States, 91204
      • Lugene Eye Institute
    • Irvine, California, United States, 92697-4375
      • The Gavin Herbert Eye Institute
    • Los Angeles, California, United States, 90067
      • Advanced Vision Care
    • Los Angeles, California, United States, 90048
      • Macy Eye Center
    • Mission Hills, California, United States
      • North Valley Eye Medical Group
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • 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
    • San Diego, California, United States, 92115
      • West Coast Eye Care Associates
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
    • Westminster, California, United States, 92683
      • Michael K Tran, M.D., Inc.
  • Florida
    • Brooksville, Florida, United States, 34613
      • Hernando Eye Institute
    • Lakeland, Florida, United States, 33805
      • Central Florida Eye Associates
    • Largo, Florida, United States, 33773
      • Shettle Eye Research, Inc
    • Ormond Beach, Florida, United States, 32174
      • International Eye Associates PA
    • Tampa, Florida, United States, 33603
      • Perez Eye Center/International Research Center
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Eye Care Centers Management, Inc. (Clayton Eye Center)
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Chicago Cornea Consultants, Ltd.
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Price Vision Group
    • New Albany, Indiana, United States, 47150
      • John-Kenyon American Eye Institute
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Cincinnati Eye Institute
    • Lexington, Kentucky, United States, 40509
      • Koffler Vision Group
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Minnesota Eye Consultants, PA
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
    • Saint Louis, Missouri, United States, 63128
      • Tekwani Vision Center
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Abrams Eye Institute
  • New York
    • New York, New York, United States, 10013
      • Raymond Fong, MDPC
    • Rockville Centre, New York, United States, 11570
      • Ophthalmic Consultants of Long Island
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
    • Winston-Salem, North Carolina, United States, 27101
      • James D Branch MD
  • Ohio
    • Westerville, Ohio, United States, 43082
      • Comprehensive Eye Care of Central Ohio
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Drs. Fine, Hoffman & Sims, LLC
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision Institute
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • Chattanooga Eye Institute, P.C.
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Nashville, Tennessee, United States, 37215
      • Toyos Clinic
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye, PA / Keystone Research, Ltd
    • El Paso, Texas, United States, 79902
      • The Cataract and Glaucoma Center
    • Houston, Texas, United States, 77055
      • Whitsett Vision Group
    • Houston, Texas, United States, 77024
      • Houston Eye Associates
    • Houston, Texas, United States, 77034
      • Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center
    • Houston, Texas, United States, 77204
      • The Ocular Surface Institute (TOSI), University of Houston
    • Lake Jackson, Texas, United States, 77566
      • Brazosport Eye Institute
    • San Antonio, Texas, United States, 78230
      • Kozlovsky Delay & Winter Eye Consultants, LLC
  • Utah
    • Draper, Utah, United States, 84020
      • Hoopes Vision
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Regional Eye Associates

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:

• Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion Criteria:

• Known hypersensitivity or contraindication to the investigational 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; or have been exposed to an investigational drug within 30 days prior to screening.
• In the opinion of the 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 0.25% Ophthalmic Suspension	Drug: KPI-121 0.25% Ophthalmic Suspension; Other Names: Loteprednol etabonate
Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspension	Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)	Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)	Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)	Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)	Comparison of ocular discomfort scores between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse using 3-day mean scores.	Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4	Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.	Baseline/Visit 2 (Day 1) - Day 4
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup	Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)	Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.	Baseline/Visit 2 (Day 1) - Day 3
Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)	Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)	Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.	Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)	Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.	Baseline/Visit 2 (Day 1) - Day 1
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)	Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)	Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.	Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)	Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)	Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

Collaborators and Investigators

• Sponsor: Kala Pharmaceuticals, Inc.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Corticosteroid; Dry Eye; Ocular Discomfort; Hyperemia
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: KPI-121-C-007

Plan for Individual participant data (IPD)

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