Clinical trial NCT02793817: Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
Official title: A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Surgical Ocular Inflammation and Pain
Keywords: postsurgical
postoperative
ocular
cataract
inflammation
pain
corticosteroid
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-08
Enrollment: 520
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 objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.

Detailed description: This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

Eligibility criteria: Inclusion Criteria:

Candidates for routine, uncomplicated cataract surgery

In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.

Exclusion Criteria:

* Known hypersensitivity/contraindication to study 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; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 18 days following surgery.
* In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Primary outcomes:
measure: Complete Resolution of Anterior Chamber (AC) Cells at Day 8
timeFrame: Visit 5 (Day 8) maintained through Visit 6 (Day 15)
measure: Complete Resolution of Ocular Pain at Day 8
timeFrame: Visit 5 (Day 8) maintained through Visit 6 (Day 15)
Secondary outcomes:
measure: Complete Resolution of Ocular Pain at Day 4
timeFrame: Visit 4 (Day 4) maintained through Visit 6 (Day 15)
measure: Complete Resolution of Anterior Chamber (AC) Flare at Day 4
timeFrame: Visit 4 (Day 4) maintained through Visit 6 (Day 15)
measure: Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4
timeFrame: Visit 1 (Baseline) and Visit 4 (Day 4)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of CA
state: Arizona
city: Artesia
country: United States
facility: Sall Research Medical 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: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center
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: 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: Fort Collins
country: United States
facility: Eye Center of Northern Colorado, PC
state: Colorado
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Largo
country: United States
facility: Shettle Eye Research, Inc
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
city: Lake Villa
country: United States
facility: Jacksoneye, S. C.
state: Illinois
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Saint Joseph
country: United States
facility: Great Lakes Eye Care
state: Michigan
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, PA
state: Minnesota
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: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Cincinnati
country: United States
facility: Apex Eye
state: Ohio
city: Roseburg
country: United States
facility: Roseburg Research Associates, LLC
state: Oregon
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Ladson
country: United States
facility: Carolina Cataract & Laser Center
state: South Carolina
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
city: Austin
country: United States
facility: Texan Eye, PA / Keystone Research, Ltd
state: Texas
city: El Paso
country: United States
facility: The Cataract & Glaucoma Center
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: San Antonio
country: United States
facility: Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research
state: Texas
Study officials:
References: