Safety and Efficacy of KPI-121 in Subjects With DED (STRIDE 3)

A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)

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: Kerato Conjunctivitis Sicca
• Intervention / Treatment: Drug: KPI-121 Ophthalmic Suspension; Drug: Vehicle

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): 901
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Investigator #133
    • Dothan, Alabama, United States, 36301
      • Investigator #278
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Investigator #146
    • Phoenix, Arizona, United States, 85032
      • Investigator #148
    • Prescott, Arizona, United States, 86301
      • Investigator #280
    • Sun City, Arizona, United States, 85351
      • Investigator #276
  • California
    • Azusa, California, United States, 91702
      • Investigator #185
    • Garden Grove, California, United States, 92843
      • Investigator #143
    • Glendale, California, United States, 91204
      • Investigator #147
    • Hemet, California, United States, 92545
      • Investigator #272
    • Inglewood, California, United States, 90301
      • Investigator #155
    • Long Beach, California, United States, 90805
      • Investigator #273
    • Mission Hills, California, United States, 91345
      • Investigator #130
    • Murrieta, California, United States, 92562
      • Investigator #247
    • Newport Beach, California, United States, 92663
      • Investigator #215
    • Rancho Cordova, California, United States, 95670
      • Site #111
    • Santa Ana, California, United States, 92705
      • Investigator #271
    • Torrance, California, United States, 90505
      • Investigator #107
    • Westminster, California, United States, 92683
      • Investigator #213
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Investigator #218
  • Florida
    • Brooksville, Florida, United States, 34613
      • Investigator #184
    • Delray Beach, Florida, United States, 33484
      • Investigator #262
    • Fort Myers, Florida, United States, 33901
      • Investigator #279
    • Jacksonville, Florida, United States, 32256
      • Investigator #265
    • Largo, Florida, United States, 33773
      • Investigator #157
    • Tampa, Florida, United States, 33603
      • Investigator #189
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Investigator #136
    • Roswell, Georgia, United States, 30076
      • Investigator #268
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Investigator #266
    • Hoffman Estates, Illinois, United States, 60169
      • Investigator #187
    • Lake Villa, Illinois, United States, 60046
      • Investigator #151
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Investigator #128
    • Indianapolis, Indiana, United States, 46290
      • Investigator #250
    • New Albany, Indiana, United States, 47150
      • Investigator #125
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Investigator #274
    • Louisville, Kentucky, United States, 40206
      • Investigator #195
    • Louisville, Kentucky, United States, 40220
      • Investigator #168
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • Investigator #219
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Investigator #267
    • Saint Louis, Missouri, United States, 63128
      • Investigator #123
    • Saint Louis, Missouri, United States, 63131
      • Investigator #106
    • Saint Louis, Missouri, United States, 63131
      • Investigator #126
    • Washington, Missouri, United States, 63090
      • Investigator #131
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Investigator #281
    • Las Vegas, Nevada, United States, 89123
      • Investigator #275
    • Las Vegas, Nevada, United States, 89145
      • Investigator #263
    • Las Vegas, Nevada, United States, 89148
      • Investigator #138
  • New York
    • New York, New York, United States, 10013
      • Investigator #105
    • Rochester, New York, United States, 14618
      • Investigator #108
    • Wantagh, New York, United States, 11793
      • Investigator #132
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Investigator #264
    • Durham, North Carolina, United States, 27704
      • Investigator #217
    • Durham, North Carolina, United States, 27710
      • Investigator #149
    • High Point, North Carolina, United States, 27262
      • Investigator #102
    • Raleigh, North Carolina, United States, 27603
      • Investigator #163
    • Southern Pines, North Carolina, United States, 28387
      • Investigator #282
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Investigator #269
    • Cincinnati, Ohio, United States, 45247
      • Investigator #142
    • Cleveland, Ohio, United States, 44115
      • Investigator #137
    • Mason, Ohio, United States, 45040
      • Investigator #171
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Investigator #224
    • Kingston, Pennsylvania, United States, 18704
      • Investigator #156
    • Lancaster, Pennsylvania, United States, 17601
      • Investigator #200
    • West Mifflin, Pennsylvania, United States, 15122
      • Investigator #277
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Investigator #240
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Investigator #127
  • Texas
    • Austin, Texas, United States, 78681
      • Investigator #270
    • Austin, Texas, United States, 78731
      • Investigator #188
    • Cedar Park, Texas, United States, 78613
      • Investigator #174
    • El Paso, Texas, United States, 79902
      • Investigator #140
    • Houston, Texas, United States, 77055
      • Investigator #124
    • Houston, Texas, United States, 77204
      • Investigator #259
    • Lakeway, Texas, United States, 78734
      • Investigator #175
    • League City, Texas, United States, 77573
      • Investigator #182
    • League City, Texas, United States, 77573
      • Investigator #191
    • San Antonio, Texas, United States, 78209
      • Site #177
    • San Antonio, Texas, United States, 78229
      • Investigator #258
    • San Antonio, Texas, United States, 78230
      • Investigator #186
    • San Antonio, Texas, United States, 78240
      • Investigator #176
  • Utah
    • Layton, Utah, United States, 84041
      • Investigator #222
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Investigator #119

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 Ophthalmic Suspension; KPI-121 Ophthalmic Suspension
Placebo Comparator: Vehicle of KPI-121 0.25% Ophthalmic Suspension	Drug: Vehicle; Vehicle for KPI-121 0.25% ophthalmic suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) 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 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 in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor	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 3 (Day 8)	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) to Visit 3 (Day 8)
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) to Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean	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) to Visit 4 (Day 15)

Collaborators and Investigators

• Sponsor: Kala Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Conjunctivitis; Keratoconjunctivitis
• Other Study ID Numbers: KPI-121-C-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No