Clinical trial NCT02813265: Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keywords: Ocular Discomfort
Pain
Corticosteroid
Hyperemia
Dry Eye
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-24
Enrollment: 918
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, 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.

Primary 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 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) in Corneal Fluorescein Staining Score 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 in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
measure: Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia 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) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
measure: Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
measure: 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.
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
measure: Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
measure: 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
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
measure: 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
timeFrame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
measure: Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)
timeFrame: Visit 4 (Day 15)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Little Rock
country: United States
facility: Eyecare Arkansas, P.A.
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Eye Clinic, LLP
state: Arkansas
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Montebello
country: United States
facility: Montebello Medical Center, Inc.
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Oceanside
country: United States
facility: Pendleton Eye Center
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado, PC
state: Colorado
city: Littleton
country: United States
facility: Corneal Consultants of Colorado
state: Colorado
city: Hamden
country: United States
facility: The Eye Center of Southern CT, P.C.
state: Connecticut
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc.
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research, Inc.
state: Florida
city: Palm Coast
country: United States
facility: Atlantic Eye Center
state: Florida
city: Panama City
country: United States
facility: The Eye Center of North Florida
state: Florida
city: Albany
country: United States
facility: Dixon Eye Care
state: Georgia
city: Lake Villa
country: United States
facility: Jacksoneye, S. C.
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Cornea Associates, LLC
state: Indiana
city: Overland Park
country: United States
facility: Stiles EyeCare Excellence and Glaucoma Institute
state: Kansas
city: Winchester
country: United States
facility: Clinical Eye Research of Boston
state: Massachusetts
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation at Pepose Vision Institute
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Consultants, Ltd.
state: Missouri
city: Las Vegas
country: United States
facility: Wellish Vision Institute
state: Nevada
city: Pennington
country: United States
facility: Matossian Eye Associates
state: New Jersey
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Slingerlands
country: United States
facility: Cornea Consultants of Albany
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Center, LLP
state: New York
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: Durham
country: United States
facility: Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
state: North Carolina
city: Raleigh
country: United States
facility: Eyecare Center
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research
state: North Dakota
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Columbus
country: United States
facility: Opthalamic Surgeons & Consultants of Ohio
state: Ohio
city: Mason
country: United States
facility: Apex Eye
state: Ohio
city: Roseburg
country: United States
facility: Roseburg Research Associates, LLC
state: Oregon
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Lancaster
country: United States
facility: Conestoga Eye
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Cedar Park
country: United States
facility: Hill Country Eye Center
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: League City
country: United States
facility: The Eye Clinic of Texas, Affiliate of Houston Eye Associates
state: Texas
city: Leander
country: United States
facility: Lake Travis Eye and Laser Center
state: Texas
city: San Antonio
country: United States
facility: Eye Clinics of South Texas
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Keystone Research - Medical Center Ophthalmology Associates
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: McLean
country: United States
facility: See Clearly Vision
state: Virginia
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
References: