Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
STRIDE 1
A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
1 other identifier
interventional
918
1 country
60
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2016
Shorter than P25 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 21, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedResults Posted
Study results publicly available
December 3, 2020
CompletedFebruary 3, 2021
January 1, 2021
1.3 years
June 21, 2016
September 21, 2020
January 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at 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.
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at 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.
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at 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.
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
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
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.
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary Outcomes (9)
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)
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)
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)
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)
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)
- +4 more secondary outcomes
Study Arms (2)
KPI-121 0.25% Ophthalmic Suspension
ACTIVE COMPARATORVehicle of KPI-121 0.25% Ophthalmic Suspension
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Have a documented clinical diagnosis of dry eye disease in both eyes
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032, United States
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260, United States
Eyecare Arkansas, P.A.
Little Rock, Arkansas, 72205, United States
Little Rock Eye Clinic, LLP
Little Rock, Arkansas, 72205, United States
Sall Research Medical Center
Artesia, California, 90701, United States
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843, United States
United Medical Research Institute
Inglewood, California, 90301, United States
North Valley Eye Medical Group
Mission Hills, California, 91345, United States
Montebello Medical Center, Inc.
Montebello, California, 90640, United States
LoBue Laser and Eye Medical Center
Murrieta, California, 92562, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Pendleton Eye Center
Oceanside, California, 92056, United States
North Bay Eye Associates, Inc.
Petaluma, California, 94954, United States
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Sacramento Eye Consultants
Sacramento, California, 95815, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80525, United States
Corneal Consultants of Colorado
Littleton, Colorado, 80209, United States
The Eye Center of Southern CT, P.C.
Hamden, Connecticut, 06518, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426, United States
Eye Associates of Fort Myers
Fort Myers, Florida, 33901, United States
Shettle Eye Research, Inc.
Largo, Florida, 33773, United States
Atlantic Eye Center
Palm Coast, Florida, 32137, United States
The Eye Center of North Florida
Panama City, Florida, 32405, United States
Dixon Eye Care
Albany, Georgia, 31701, United States
Jacksoneye, S. C.
Lake Villa, Illinois, 60046, United States
Midwest Cornea Associates, LLC
Indianapolis, Indiana, 46290, United States
Stiles EyeCare Excellence and Glaucoma Institute
Overland Park, Kansas, 66213, United States
Clinical Eye Research of Boston
Winchester, Massachusetts, 01890, United States
Chu Vision Institute
Bloomington, Minnesota, 55420, United States
Lifelong Vision Foundation at Pepose Vision Institute
Chesterfield, Missouri, 63017, United States
Ophthalmology Associates
St Louis, Missouri, 63131, United States
Ophthalmology Consultants, Ltd.
St Louis, Missouri, 63131, United States
Wellish Vision Institute
Las Vegas, Nevada, 89119, United States
Matossian Eye Associates
Pennington, New Jersey, 08534, United States
Rochester Ophthalmological Group, PC
Rochester, New York, 14618, United States
Cornea Consultants of Albany
Slingerlands, New York, 12159, United States
South Shore Eye Center, LLP
Wantagh, New York, 11793, United States
Mundorf Eye Center
Charlotte, North Carolina, 28204, United States
Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
Durham, North Carolina, 27704, United States
Eyecare Center
Raleigh, North Carolina, 27603, United States
Bergstrom Eye Research
Fargo, North Dakota, 58103, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
Opthalamic Surgeons & Consultants of Ohio
Columbus, Ohio, 43215, United States
Apex Eye
Mason, Ohio, 45040, United States
Roseburg Research Associates, LLC
Roseburg, Oregon, 97471, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066, United States
Conestoga Eye
Lancaster, Pennsylvania, 17601, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
Hill Country Eye Center
Cedar Park, Texas, 78613, United States
Houston Eye Associates
Houston, Texas, 77025, United States
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
League City, Texas, 77573, United States
Lake Travis Eye and Laser Center
Leander, Texas, 78641, United States
Eye Clinics of South Texas
San Antonio, Texas, 78209, United States
R and R Eye Research, LLC
San Antonio, Texas, 78229, United States
Keystone Research - Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Tanner Clinic
Layton, Utah, 84041, United States
See Clearly Vision
McLean, Virginia, 22102, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Clinical Development
- Organization
- Kala Pharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2016
First Posted
June 24, 2016
Study Start
June 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
February 3, 2021
Results First Posted
December 3, 2020
Record last verified: 2021-01