Clinical trial NCT03616899: Safety and Efficacy of KPI-121 in Subjects With DED
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kerato Conjunctivitis Sicca
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 901
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
measure: 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
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary outcomes:
measure: Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
measure: Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
measure: Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)
timeFrame: Baseline/Visit 2 (Day 1) to Visit 3 (Day 8)
measure: Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
measure: Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean
timeFrame: Baseline/Visit 2 (Day 1) to Visit 4 (Day 15)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigator #133
state: Alabama
city: Dothan
country: United States
facility: Investigator #278
state: Alabama
city: Chandler
country: United States
facility: Investigator #146
state: Arizona
city: Phoenix
country: United States
facility: Investigator #148
state: Arizona
city: Prescott
country: United States
facility: Investigator #280
state: Arizona
city: Sun City
country: United States
facility: Investigator #276
state: Arizona
city: Azusa
country: United States
facility: Investigator #185
state: California
city: Garden Grove
country: United States
facility: Investigator #143
state: California
city: Glendale
country: United States
facility: Investigator #147
state: California
city: Hemet
country: United States
facility: Investigator #272
state: California
city: Inglewood
country: United States
facility: Investigator #155
state: California
city: Long Beach
country: United States
facility: Investigator #273
state: California
city: Mission Hills
country: United States
facility: Investigator #130
state: California
city: Murrieta
country: United States
facility: Investigator #247
state: California
city: Newport Beach
country: United States
facility: Investigator #215
state: California
city: Rancho Cordova
country: United States
facility: Site #111
state: California
city: Santa Ana
country: United States
facility: Investigator #271
state: California
city: Torrance
country: United States
facility: Investigator #107
state: California
city: Westminster
country: United States
facility: Investigator #213
state: California
city: Littleton
country: United States
facility: Investigator #218
state: Colorado
city: Brooksville
country: United States
facility: Investigator #184
state: Florida
city: Delray Beach
country: United States
facility: Investigator #262
state: Florida
city: Fort Myers
country: United States
facility: Investigator #279
state: Florida
city: Jacksonville
country: United States
facility: Investigator #265
state: Florida
city: Largo
country: United States
facility: Investigator #157
state: Florida
city: Tampa
country: United States
facility: Investigator #189
state: Florida
city: Morrow
country: United States
facility: Investigator #136
state: Georgia
city: Roswell
country: United States
facility: Investigator #268
state: Georgia
city: Chicago
country: United States
facility: Investigator #266
state: Illinois
city: Hoffman Estates
country: United States
facility: Investigator #187
state: Illinois
city: Lake Villa
country: United States
facility: Investigator #151
state: Illinois
city: Indianapolis
country: United States
facility: Investigator #128
state: Indiana
city: Indianapolis
country: United States
facility: Investigator #250
state: Indiana
city: New Albany
country: United States
facility: Investigator #125
state: Indiana
city: Lexington
country: United States
facility: Investigator #274
state: Kentucky
city: Louisville
country: United States
facility: Investigator #195
state: Kentucky
city: Louisville
country: United States
facility: Investigator #168
state: Kentucky
city: Winchester
country: United States
facility: Investigator #219
state: Massachusetts
city: Kansas City
country: United States
facility: Investigator #267
state: Missouri
city: Saint Louis
country: United States
facility: Investigator #123
state: Missouri
city: Saint Louis
country: United States
facility: Investigator #106
state: Missouri
city: Saint Louis
country: United States
facility: Investigator #126
state: Missouri
city: Washington
country: United States
facility: Investigator #131
state: Missouri
city: Henderson
country: United States
facility: Investigator #281
state: Nevada
city: Las Vegas
country: United States
facility: Investigator #275
state: Nevada
city: Las Vegas
country: United States
facility: Investigator #263
state: Nevada
city: Las Vegas
country: United States
facility: Investigator #138
state: Nevada
city: New York
country: United States
facility: Investigator #105
state: New York
city: Rochester
country: United States
facility: Investigator #108
state: New York
city: Wantagh
country: United States
facility: Investigator #132
state: New York
city: Asheville
country: United States
facility: Investigator #264
state: North Carolina
city: Durham
country: United States
facility: Investigator #217
state: North Carolina
city: Durham
country: United States
facility: Investigator #149
state: North Carolina
city: High Point
country: United States
facility: Investigator #102
state: North Carolina
city: Raleigh
country: United States
facility: Investigator #163
state: North Carolina
city: Southern Pines
country: United States
facility: Investigator #282
state: North Carolina
city: Cincinnati
country: United States
facility: Investigator #269
state: Ohio
city: Cincinnati
country: United States
facility: Investigator #142
state: Ohio
city: Cleveland
country: United States
facility: Investigator #137
state: Ohio
city: Mason
country: United States
facility: Investigator #171
state: Ohio
city: Cranberry Township
country: United States
facility: Investigator #224
state: Pennsylvania
city: Kingston
country: United States
facility: Investigator #156
state: Pennsylvania
city: Lancaster
country: United States
facility: Investigator #200
state: Pennsylvania
city: West Mifflin
country: United States
facility: Investigator #277
state: Pennsylvania
city: Rapid City
country: United States
facility: Investigator #240
state: South Dakota
city: Memphis
country: United States
facility: Investigator #127
state: Tennessee
city: Austin
country: United States
facility: Investigator #270
state: Texas
city: Austin
country: United States
facility: Investigator #188
state: Texas
city: Cedar Park
country: United States
facility: Investigator #174
state: Texas
city: El Paso
country: United States
facility: Investigator #140
state: Texas
city: Houston
country: United States
facility: Investigator #124
state: Texas
city: Houston
country: United States
facility: Investigator #259
state: Texas
city: Lakeway
country: United States
facility: Investigator #175
state: Texas
city: League City
country: United States
facility: Investigator #182
state: Texas
city: League City
country: United States
facility: Investigator #191
state: Texas
city: San Antonio
country: United States
facility: Site #177
state: Texas
city: San Antonio
country: United States
facility: Investigator #258
state: Texas
city: San Antonio
country: United States
facility: Investigator #186
state: Texas
city: San Antonio
country: United States
facility: Investigator #176
state: Texas
city: Layton
country: United States
facility: Investigator #222
state: Utah
city: Norfolk
country: United States
facility: Investigator #119
state: Virginia
Study officials:
References: