Safety and Efficacy of KPI-121 in Subjects With DED

Phase 3

Completed

Conditions: Kerato Conjunctivitis Sicca

Interventions: Drug: KPI-121 Ophthalmic Suspension
Drug: Vehicle

Registration Number: NCT03616899

Lead Sponsor: Kala Pharmaceuticals, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 901

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KPI-121 0.25% Ophthalmic Suspension	KPI-121 Ophthalmic Suspension	-
Vehicle of KPI-121 0.25% Ophthalmic Suspension	Vehicle	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)	Baseline/Visit 2 (Day 1) and to 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	Baseline/Visit 2 (Day 1) and to 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, in a sub-group of participants with more severe ocular discomfort at baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)	Baseline/Visit 2 (Day 1) and to 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 From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean	Baseline/Visit 2 (Day 1) to 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 in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor	Baseline/Visit 2 (Day 1) and to 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 From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)	Baseline/Visit 2 (Day 1) to 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)	Baseline/Visit 2 (Day 1) to 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.

Trial Locations

Locations (81): Investigator #278
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Dothan, Alabama, United States
Investigator #213
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Westminster, California, United States
Investigator #268
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Roswell, Georgia, United States
Investigator #265
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Jacksonville, Florida, United States
Site #111
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Rancho Cordova, California, United States
Investigator #151
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Lake Villa, Illinois, United States
Investigator #136
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Morrow, Georgia, United States
Investigator #219
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Winchester, Massachusetts, United States
Investigator #218
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Littleton, Colorado, United States
Investigator #107
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Torrance, California, United States
Investigator #157
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Largo, Florida, United States
Investigator #106
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Saint Louis, Missouri, United States
Investigator #215
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Newport Beach, California, United States
Investigator #130
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Mission Hills, California, United States
Investigator #125
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New Albany, Indiana, United States
Investigator #262
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Delray Beach, Florida, United States
Investigator #266
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Chicago, Illinois, United States
Investigator #146
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Chandler, Arizona, United States
Investigator #184
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Brooksville, Florida, United States
Investigator #273
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Long Beach, California, United States
Investigator #247
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Murrieta, California, United States
Investigator #187
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Hoffman Estates, Illinois, United States
Investigator #281
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Henderson, Nevada, United States
Investigator #105
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New York, New York, United States
Investigator #128
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Indianapolis, Indiana, United States
Investigator #250
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Indianapolis, Indiana, United States
Investigator #275
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Las Vegas, Nevada, United States
Investigator #263
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Las Vegas, Nevada, United States
Investigator #269
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Cincinnati, Ohio, United States
Investigator #142
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Cincinnati, Ohio, United States
Investigator #259
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Houston, Texas, United States
Investigator #126
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Saint Louis, Missouri, United States
Investigator #276
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Sun City, Arizona, United States
Investigator #280
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Prescott, Arizona, United States
Investigator #185
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Azusa, California, United States
Investigator #143
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Garden Grove, California, United States
Investigator #147
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Glendale, California, United States
Investigator #272
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Hemet, California, United States
Investigator #271
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Santa Ana, California, United States
Investigator #155
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Inglewood, California, United States
Investigator #274
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Lexington, Kentucky, United States
Investigator #123
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Saint Louis, Missouri, United States
Investigator #131
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Washington, Missouri, United States
Investigator #138
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Las Vegas, Nevada, United States
Investigator #108
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Rochester, New York, United States
Investigator #132
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Wantagh, New York, United States
Investigator #264
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Asheville, North Carolina, United States
Investigator #102
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High Point, North Carolina, United States
Investigator #163
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Raleigh, North Carolina, United States
Investigator #282
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Southern Pines, North Carolina, United States
Investigator #137
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Cleveland, Ohio, United States
Investigator #171
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Mason, Ohio, United States
Investigator #224
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Cranberry Township, Pennsylvania, United States
Investigator #156
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Kingston, Pennsylvania, United States
Investigator #200
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Lancaster, Pennsylvania, United States
Investigator #277
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West Mifflin, Pennsylvania, United States
Investigator #240
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Rapid City, South Dakota, United States
Investigator #127
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Memphis, Tennessee, United States
Investigator #124
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Houston, Texas, United States
Investigator #174
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Cedar Park, Texas, United States
Investigator #140
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El Paso, Texas, United States
Investigator #175
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Lakeway, Texas, United States
Investigator #182
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League City, Texas, United States
Investigator #191
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League City, Texas, United States
Site #177
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San Antonio, Texas, United States
Investigator #119
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Norfolk, Virginia, United States
Investigator #222
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Layton, Utah, United States
Investigator #279
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Fort Myers, Florida, United States
Investigator #133
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Birmingham, Alabama, United States
Investigator #217
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Durham, North Carolina, United States
Investigator #186
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San Antonio, Texas, United States
Investigator #176
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San Antonio, Texas, United States
Investigator #148
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Phoenix, Arizona, United States
Investigator #168
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Louisville, Kentucky, United States
Investigator #149
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Durham, North Carolina, United States
Investigator #189
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Tampa, Florida, United States
Investigator #195
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Louisville, Kentucky, United States
Investigator #267
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Kansas City, Missouri, United States
Investigator #258
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San Antonio, Texas, United States
Investigator #270
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Austin, Texas, United States
Investigator #188
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Austin, Texas, United States