Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
- Conditions
- Keratoconjunctivitis SiccaDry Eye Syndromes
- Interventions
- Drug: KPI-121 0.25% Ophthalmic SuspensionDrug: Vehicle of KPI-121 0.25% Ophthalmic Suspension
- Registration Number
- NCT02813265
- 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
- 918
- Have a documented clinical diagnosis of dry eye disease in both eyes
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KPI-121 0.25% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension - Vehicle of KPI-121 0.25% Ophthalmic Suspension Vehicle of KPI-121 0.25% Ophthalmic Suspension -
- Primary 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 Corneal Fluorescein Staining Score at Visit 4 (Day 15) Baseline/Visit 2 (Day 1) and 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.
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 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 Baseline/Visit 2 (Day 1) and 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, in a sub-group of participants with more severe ocular discomfort at baseline.
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 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 in a sub-group of participants with more severe ocular discomfort at baseline.. 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.
Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15) 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) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal) 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 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. Baseline/Visit 2 (Day 1) and 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 in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) Baseline/Visit 2 (Day 1) and 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.
Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15) Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15) Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores. 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 in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1) Baseline/Visit 2 (Day 1) and 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 in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1) 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.
Trial Locations
- Locations (60)
Cornea and Cataract Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Schwartz Laser Eye Center
🇺🇸Scottsdale, Arizona, United States
Eyecare Arkansas, P.A.
🇺🇸Little Rock, Arkansas, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
Orange County Ophthalmology Medical Group
🇺🇸Garden Grove, California, United States
North Valley Eye Medical Group
🇺🇸Mission Hills, California, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
Montebello Medical Center, Inc.
🇺🇸Montebello, California, United States
LoBue Laser and Eye Medical Center
🇺🇸Murrieta, California, United States
Pendleton Eye Center
🇺🇸Oceanside, California, United States
North Bay Eye Associates, Inc.
🇺🇸Petaluma, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Sacramento Eye Consultants
🇺🇸Sacramento, California, United States
Eye Center of Northern Colorado, PC
🇺🇸Fort Collins, Colorado, United States
Corneal Consultants of Colorado
🇺🇸Littleton, Colorado, United States
Florida Eye Microsurgical Institute, Inc.
🇺🇸Boynton Beach, Florida, United States
Eye Associates of Fort Myers
🇺🇸Fort Myers, Florida, United States
Shettle Eye Research, Inc.
🇺🇸Largo, Florida, United States
Atlantic Eye Center
🇺🇸Palm Coast, Florida, United States
The Eye Center of North Florida
🇺🇸Panama City, Florida, United States
Dixon Eye Care
🇺🇸Albany, Georgia, United States
Jacksoneye, S. C.
🇺🇸Lake Villa, Illinois, United States
Midwest Cornea Associates, LLC
🇺🇸Indianapolis, Indiana, United States
Clinical Eye Research of Boston
🇺🇸Winchester, Massachusetts, United States
Lifelong Vision Foundation at Pepose Vision Institute
🇺🇸Chesterfield, Missouri, United States
Chu Vision Institute
🇺🇸Bloomington, Minnesota, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Ophthalmology Consultants, Ltd.
🇺🇸Saint Louis, Missouri, United States
Cornea Consultants of Albany
🇺🇸Slingerlands, New York, United States
South Shore Eye Center, LLP
🇺🇸Wantagh, New York, United States
Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
🇺🇸Durham, North Carolina, United States
Mundorf Eye Center
🇺🇸Charlotte, North Carolina, United States
Eyecare Center
🇺🇸Raleigh, North Carolina, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
Opthalamic Surgeons & Consultants of Ohio
🇺🇸Columbus, Ohio, United States
Apex Eye
🇺🇸Mason, Ohio, United States
Roseburg Research Associates, LLC
🇺🇸Roseburg, Oregon, United States
Conestoga Eye
🇺🇸Lancaster, Pennsylvania, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
UPMC Eye Center
🇺🇸Pittsburgh, Pennsylvania, United States
Hill Country Eye Center
🇺🇸Cedar Park, Texas, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
🇺🇸League City, Texas, United States
Lake Travis Eye and Laser Center
🇺🇸Leander, Texas, United States
See Clearly Vision
🇺🇸McLean, Virginia, United States
Keystone Research - Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Stiles EyeCare Excellence and Glaucoma Institute
🇺🇸Overland Park, Kansas, United States
Bergstrom Eye Research
🇺🇸Fargo, North Dakota, United States
Little Rock Eye Clinic, LLP
🇺🇸Little Rock, Arkansas, United States
Matossian Eye Associates
🇺🇸Pennington, New Jersey, United States
The Eye Center of Southern CT, P.C.
🇺🇸Hamden, Connecticut, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Wellish Vision Institute
🇺🇸Las Vegas, Nevada, United States
Rochester Ophthalmological Group, PC
🇺🇸Rochester, New York, United States
Eye Clinics of South Texas
🇺🇸San Antonio, Texas, United States
R and R Eye Research, LLC
🇺🇸San Antonio, Texas, United States