Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
STRIDE 2
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
909
1 country
62
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
62 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 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
December 3, 2020
CompletedJanuary 5, 2021
November 1, 2020
1.3 years
June 28, 2016
September 21, 2020
December 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye 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) - 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 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) - Visit 4 (Day 15)
Secondary Outcomes (12)
Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)
Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4
Baseline/Visit 2 (Day 1) - Day 4
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)
Baseline/Visit 2 (Day 1) - Day 3
- +7 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, 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 (62)
UAB School of Optometry
Birmingham, Alabama, 35294-0010, United States
Arizona Eye Center
Chandler, Arizona, 85225, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Sall Research Medical Center
Artesia, California, 90701, United States
Milton M. Hom, OD, FAAO
Azusa, California, 91702, United States
Family Eye Care Center
Campbell, California, 95008, United States
Orange County Ophthalmology
Garden Grove, California, 92843, United States
Lugene Eye Institute
Glendale, California, 91204, United States
The Gavin Herbert Eye Institute
Irvine, California, 92697-4375, United States
Macy Eye Center
Los Angeles, California, 90048, United States
Advanced Vision Care
Los Angeles, California, 90067, United States
North Valley Eye Medical Group
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Arch Health Partners
Poway, California, 92064, United States
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Shasta Eye Medical Group, Inc
Redding, California, 96002, United States
West Coast Eye Care Associates
San Diego, California, 92115, United States
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
Michael K Tran, M.D., Inc.
Westminster, California, 92683, United States
Hernando Eye Institute
Brooksville, Florida, 34613, United States
Central Florida Eye Associates
Lakeland, Florida, 33805, United States
Shettle Eye Research, Inc
Largo, Florida, 33773, United States
International Eye Associates PA
Ormond Beach, Florida, 32174, United States
Perez Eye Center/International Research Center
Tampa, Florida, 33603, United States
Eye Care Centers Management, Inc. (Clayton Eye Center)
Morrow, Georgia, 30260, United States
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, 60169, United States
Price Vision Group
Indianapolis, Indiana, 46260, United States
John-Kenyon American Eye Institute
New Albany, Indiana, 47150, United States
Cincinnati Eye Institute
Edgewood, Kentucky, 41017, United States
Koffler Vision Group
Lexington, Kentucky, 40509, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431, United States
Tauber Eye Center
Kansas City, Missouri, 64111, United States
Tekwani Vision Center
St Louis, Missouri, 63128, United States
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
Washington, Missouri, 63090, United States
Abrams Eye Institute
Las Vegas, Nevada, 89148, United States
Raymond Fong, MDPC
New York, New York, 10013, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570, United States
Cornerstone Eye Care
High Point, North Carolina, 27262, United States
James D Branch MD
Winston-Salem, North Carolina, 27101, United States
Comprehensive Eye Care of Central Ohio
Westerville, Ohio, 43082, United States
Drs. Fine, Hoffman & Sims, LLC
Eugene, Oregon, 97401, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066, United States
Eye Care Specialists
Kingston, Pennsylvania, 18704, United States
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702, United States
Chattanooga Eye Institute, P.C.
Chattanooga, Tennessee, 37411, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
Toyos Clinic
Nashville, Tennessee, 37215, United States
Texan Eye, PA / Keystone Research, Ltd
Austin, Texas, 78731, United States
The Cataract and Glaucoma Center
El Paso, Texas, 79902, United States
Houston Eye Associates
Houston, Texas, 77024, United States
Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center
Houston, Texas, 77034, United States
Whitsett Vision Group
Houston, Texas, 77055, United States
The Ocular Surface Institute (TOSI), University of Houston
Houston, Texas, 77204, United States
Brazosport Eye Institute
Lake Jackson, Texas, 77566, United States
Kozlovsky Delay & Winter Eye Consultants, LLC
San Antonio, Texas, 78230, United States
Hoopes Vision
Draper, Utah, 84020, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Regional Eye Associates
Morgantown, West Virginia, 26505, 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 28, 2016
First Posted
June 30, 2016
Study Start
June 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
January 5, 2021
Results First Posted
December 3, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share