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

Primary Purpose

Kerato Conjunctivitis Sicca

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
KPI-121 Ophthalmic Suspension
Vehicle
Sponsored by
Kala Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kerato Conjunctivitis Sicca

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator #133
  • Investigator #278
  • Investigator #146
  • Investigator #148
  • Investigator #280
  • Investigator #276
  • Investigator #185
  • Investigator #143
  • Investigator #147
  • Investigator #272
  • Investigator #155
  • Investigator #273
  • Investigator #130
  • Investigator #247
  • Investigator #215
  • Site #111
  • Investigator #271
  • Investigator #107
  • Investigator #213
  • Investigator #218
  • Investigator #184
  • Investigator #262
  • Investigator #279
  • Investigator #265
  • Investigator #157
  • Investigator #189
  • Investigator #136
  • Investigator #268
  • Investigator #266
  • Investigator #187
  • Investigator #151
  • Investigator #128
  • Investigator #250
  • Investigator #125
  • Investigator #274
  • Investigator #195
  • Investigator #168
  • Investigator #219
  • Investigator #267
  • Investigator #123
  • Investigator #106
  • Investigator #126
  • Investigator #131
  • Investigator #281
  • Investigator #275
  • Investigator #263
  • Investigator #138
  • Investigator #105
  • Investigator #108
  • Investigator #132
  • Investigator #264
  • Investigator #217
  • Investigator #149
  • Investigator #102
  • Investigator #163
  • Investigator #282
  • Investigator #269
  • Investigator #142
  • Investigator #137
  • Investigator #171
  • Investigator #224
  • Investigator #156
  • Investigator #200
  • Investigator #277
  • Investigator #240
  • Investigator #127
  • Investigator #270
  • Investigator #188
  • Investigator #174
  • Investigator #140
  • Investigator #124
  • Investigator #259
  • Investigator #175
  • Investigator #182
  • Investigator #191
  • Site #177
  • Investigator #258
  • Investigator #186
  • Investigator #176
  • Investigator #222
  • Investigator #119

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

KPI-121 0.25% Ophthalmic Suspension

Vehicle of KPI-121 0.25% Ophthalmic Suspension

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
July 31, 2018
Last Updated
March 9, 2021
Sponsor
Kala Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03616899
Brief Title
Safety and Efficacy of KPI-121 in Subjects With DED
Acronym
STRIDE 3
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kala Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kerato Conjunctivitis Sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KPI-121 0.25% Ophthalmic Suspension
Arm Type
Active Comparator
Arm Title
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KPI-121 Ophthalmic Suspension
Intervention Description
KPI-121 Ophthalmic Suspension
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle for KPI-121 0.25% ophthalmic suspension
Primary Outcome Measure Information:
Title
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Title
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
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary Outcome Measure Information:
Title
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Title
Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) to Visit 3 (Day 8)
Title
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigator #133
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Investigator #278
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Investigator #146
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Investigator #148
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Investigator #280
City
Prescott
State/Province
Arizona
ZIP/Postal Code
86301
Country
United States
Facility Name
Investigator #276
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Investigator #185
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Investigator #143
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Investigator #147
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Investigator #272
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
Investigator #155
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Investigator #273
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Investigator #130
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Investigator #247
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Investigator #215
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Site #111
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Investigator #271
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Investigator #107
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Investigator #213
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Investigator #218
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Investigator #184
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Investigator #262
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Investigator #279
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Investigator #265
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Investigator #157
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Investigator #189
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Investigator #136
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Investigator #268
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Investigator #266
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Investigator #187
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Investigator #151
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Investigator #128
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Investigator #250
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Investigator #125
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Investigator #274
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Facility Name
Investigator #195
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Investigator #168
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Investigator #219
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Investigator #267
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Investigator #123
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Investigator #106
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Investigator #126
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Investigator #131
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Investigator #281
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Investigator #275
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Investigator #263
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Investigator #138
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Investigator #105
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
Investigator #108
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Investigator #132
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Investigator #264
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Investigator #217
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Investigator #149
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigator #102
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Investigator #163
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Investigator #282
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Investigator #269
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Investigator #142
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
Investigator #137
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Investigator #171
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Investigator #224
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Investigator #156
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Investigator #200
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Investigator #277
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Investigator #240
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Investigator #127
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Investigator #270
City
Austin
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Investigator #188
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Investigator #174
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Investigator #140
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Investigator #124
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Investigator #259
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
Investigator #175
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
Investigator #182
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Investigator #191
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Site #177
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Investigator #258
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigator #186
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Investigator #176
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Investigator #222
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Investigator #119
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of KPI-121 in Subjects With DED

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