Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (STRIDE 1)

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): 918
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of Arizona
    • Scottsdale, Arizona, United States, 85260
      • Schwartz Laser Eye Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Eyecare Arkansas, P.A.
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Eye Clinic, LLP
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology Medical Group
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group
    • Montebello, California, United States, 90640
      • Montebello Medical Center, Inc.
    • Murrieta, California, United States, 92562
      • LoBue Laser and Eye Medical Center
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Oceanside, California, United States, 92056
      • Pendleton Eye Center
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.
    • Rancho Cordova, California, United States, 95670
      • Martel Eye Medical Group
    • Sacramento, California, United States, 95815
      • Sacramento Eye Consultants
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Eye Center of Northern Colorado, PC
    • Littleton, Colorado, United States, 80209
      • Corneal Consultants of Colorado
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • The Eye Center of Southern CT, P.C.
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Florida Eye Microsurgical Institute, Inc.
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers
    • Largo, Florida, United States, 33773
      • Shettle Eye Research, Inc.
    • Palm Coast, Florida, United States, 32137
      • Atlantic Eye Center
    • Panama City, Florida, United States, 32405
      • The Eye Center of North Florida
  • Georgia
    • Albany, Georgia, United States, 31701
      • Dixon Eye Care
  • Illinois
    • Lake Villa, Illinois, United States, 60046
      • Jacksoneye, S. C.
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Midwest Cornea Associates, LLC
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • Stiles Eyecare Excellence and Glaucoma Institute
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • Clinical Eye Research of Boston
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Chu Vision Institute
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Lifelong Vision Foundation at Pepose Vision Institute
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Consultants, Ltd.
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Wellish Vision Institute
  • New Jersey
    • Pennington, New Jersey, United States, 08534
      • Matossian Eye Associates
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
    • Slingerlands, New York, United States, 12159
      • Cornea Consultants of Albany
    • Wantagh, New York, United States, 11793
      • South Shore Eye Center, LLP
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mundorf Eye Center
    • Durham, North Carolina, United States, 27704
      • Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
    • Raleigh, North Carolina, United States, 27603
      • Eyecare Center
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bergstrom Eye Research
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
    • Columbus, Ohio, United States, 43215
      • Opthalamic Surgeons & Consultants of Ohio
    • Mason, Ohio, United States, 45040
      • Apex Eye
  • Oregon
    • Roseburg, Oregon, United States, 97471
      • Roseburg Research Associates, LLC
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
    • Lancaster, Pennsylvania, United States, 17601
      • Conestoga Eye
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Eye Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Hill Country Eye Center
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • League City, Texas, United States, 77573
      • The Eye Clinic of Texas, Affiliate of Houston Eye Associates
    • Leander, Texas, United States, 78641
      • Lake Travis Eye and Laser Center
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research, LLC
    • San Antonio, Texas, United States, 78209
      • Eye Clinics of South Texas
    • San Antonio, Texas, United States, 78240
      • Keystone Research - Medical Center Ophthalmology Associates
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic
  • Virginia
    • McLean, Virginia, United States, 22102
      • See Clearly Vision
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

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, 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; 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 bulbar conjunctival hyperemia 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) and to 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 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) and to Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)	Comparison of mean corneal fluorescein staining 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) and to Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort	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, in a sub-group of participants with more severe ocular discomfort at baseline.	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)	Comparison of mean bulbar conjunctival hyperemia 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) and to Visit 4 (Day 15)
Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)	Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores. 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) and to Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)	Comparison of mean bulbar conjunctival hyperemia 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) and to Visit 4 (Day 15)
Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)	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) and to Visit 3 (Day 8)
Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort.	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) and to Visit 3 (Day 8)
Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)	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) and to Visit 3 (Day 8)
Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort	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, in a sub-group of participants with more severe ocular discomfort at baseline.	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort	Comparison of mean bulbar conjunctival hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale in a sub-group of participants with more severe ocular discomfort at baseline.. 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) and to Visit 4 (Day 15)
Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)	Comparison of mean bulbar conjunctival hyperemia 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	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): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

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-006