Clinical trial NCT02819284: Safety and Efficacy of KPI-121 Compared to Placebo 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: 2016-06-30
Enrollment: 909
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 Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) - 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) - Visit 4 (Day 15)
Secondary outcomes:
measure: Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
measure: Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)
timeFrame: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
measure: Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4
timeFrame: Baseline/Visit 2 (Day 1) - Day 4
measure: Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup
timeFrame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
measure: Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)
timeFrame: Baseline/Visit 2 (Day 1) - Day 3
measure: Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
measure: Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)
timeFrame: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
measure: Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)
timeFrame: Baseline/Visit 2 (Day 1) - Day 1
measure: Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
measure: Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)
timeFrame: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
measure: Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
measure: Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)
timeFrame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Optometry
state: Alabama
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO
state: California
city: Campbell
country: United States
facility: Family Eye Care Center
state: California
city: Garden Grove
country: United States
facility: Orange County Ophthalmology
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Irvine
country: United States
facility: The Gavin Herbert Eye Institute
state: California
city: Los Angeles
country: United States
facility: Macy Eye Center
state: California
city: Los Angeles
country: United States
facility: Advanced Vision Care
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Poway
country: United States
facility: Arch Health Partners
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc
state: California
city: San Diego
country: United States
facility: West Coast Eye Care Associates
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Westminster
country: United States
facility: Michael K Tran, M.D., Inc.
state: California
city: Brooksville
country: United States
facility: Hernando Eye Institute
state: Florida
city: Lakeland
country: United States
facility: Central Florida Eye Associates
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research, Inc
state: Florida
city: Ormond Beach
country: United States
facility: International Eye Associates PA
state: Florida
city: Tampa
country: United States
facility: Perez Eye Center/International Research Center
state: Florida
city: Morrow
country: United States
facility: Eye Care Centers Management, Inc. (Clayton Eye Center)
state: Georgia
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: New Albany
country: United States
facility: John-Kenyon American Eye Institute
state: Indiana
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Lexington
country: United States
facility: Koffler Vision Group
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, PA
state: Minnesota
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Abrams Eye Institute
state: Nevada
city: New York
country: United States
facility: Raymond Fong, MDPC
state: New York
city: Rockville Centre
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Winston-Salem
country: United States
facility: James D Branch MD
state: North Carolina
city: Westerville
country: United States
facility: Comprehensive Eye Care of Central Ohio
state: Ohio
city: Eugene
country: United States
facility: Drs. Fine, Hoffman & Sims, LLC
state: Oregon
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Eye Institute, P.C.
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: Austin
country: United States
facility: Texan Eye, PA / Keystone Research, Ltd
state: Texas
city: El Paso
country: United States
facility: The Cataract and Glaucoma Center
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: Houston
country: United States
facility: The Ocular Surface Institute (TOSI), University of Houston
state: Texas
city: Lake Jackson
country: United States
facility: Brazosport Eye Institute
state: Texas
city: San Antonio
country: United States
facility: Kozlovsky Delay & Winter Eye Consultants, LLC
state: Texas
city: Draper
country: United States
facility: Hoopes Vision
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Morgantown
country: United States
facility: Regional Eye Associates
state: West Virginia
Study officials:
References: