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Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease (STRIDE 2)

Primary Purpose

Dry Eye Syndromes, Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
KPI-121 0.25% Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Sponsored by
Kala Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Ocular Discomfort, Pain, Corticosteroid, Hyperemia, Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB School of Optometry
  • Arizona Eye Center
  • NEA Baptist Clinic
  • Sall Research Medical Center
  • Milton M. Hom, OD, FAAO
  • Family Eye Care Center
  • Orange County Ophthalmology
  • Lugene Eye Institute
  • The Gavin Herbert Eye Institute
  • Macy Eye Center
  • Advanced Vision Care
  • North Valley Eye Medical Group
  • Eye Research Foundation
  • Arch Health Partners
  • Martel Eye Medical Group
  • Shasta Eye Medical Group, Inc
  • West Coast Eye Care Associates
  • Wolstan & Goldberg Eye Associates
  • Michael K Tran, M.D., Inc.
  • Hernando Eye Institute
  • Central Florida Eye Associates
  • Shettle Eye Research, Inc
  • International Eye Associates PA
  • Perez Eye Center/International Research Center
  • Eye Care Centers Management, Inc. (Clayton Eye Center)
  • Chicago Cornea Consultants, Ltd.
  • Price Vision Group
  • John-Kenyon American Eye Institute
  • Cincinnati Eye Institute
  • Koffler Vision Group
  • The Eye Care Institute
  • Taustine Eye Center
  • Ophthalmic Consultants of Boston
  • Minnesota Eye Consultants, PA
  • Tauber Eye Center
  • Tekwani Vision Center
  • Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
  • Abrams Eye Institute
  • Raymond Fong, MDPC
  • Ophthalmic Consultants of Long Island
  • Cornerstone Eye Care
  • James D Branch MD
  • Comprehensive Eye Care of Central Ohio
  • Drs. Fine, Hoffman & Sims, LLC
  • Scott & Christie and Associates, PC
  • Eye Care Specialists
  • Bucci Laser Vision Institute
  • Chattanooga Eye Institute, P.C.
  • Total Eye Care, PA
  • Toyos Clinic
  • Texan Eye, PA / Keystone Research, Ltd
  • The Cataract and Glaucoma Center
  • Houston Eye Associates
  • Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center
  • Whitsett Vision Group
  • The Ocular Surface Institute (TOSI), University of Houston
  • Brazosport Eye Institute
  • Kozlovsky Delay & Winter Eye Consultants, LLC
  • Hoopes Vision
  • Virginia Eye Consultants
  • Spokane Eye Clinical Research
  • Regional Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

KPI-121 0.25% Ophthalmic Suspension

Vehicle of KPI-121 0.25% Ophthalmic Suspension

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)
Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. 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 Ocular Discomfort Severity Scores at Visit 3 (Day 8)
Comparison of ocular discomfort scores 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 using 3-day mean scores.
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4
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.
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup
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, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means.
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)
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) in Eye Dryness Scores at Visit 4 (Day 15)
Comparison of mean eye dryness 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) in Eye Dryness Scores at Visit 3 (Day 8)
Comparison of mean eye dryness 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.
Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)
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.
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)
Comparison of mean ocular discomfort frequency 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) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)
Comparison of mean ocular discomfort frequency 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) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Comparison of mean corneal fluorescein staining in the study eye 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 Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Comparison of mean nasal corneal fluorescein staining in the study eye 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.

Full Information

First Posted
June 28, 2016
Last Updated
December 10, 2020
Sponsor
Kala Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02819284
Brief Title
Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
Acronym
STRIDE 2
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kala Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Keratoconjunctivitis Sicca
Keywords
Ocular Discomfort, Pain, Corticosteroid, Hyperemia, Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
909 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KPI-121 0.25% Ophthalmic Suspension
Arm Type
Active Comparator
Arm Title
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KPI-121 0.25% Ophthalmic Suspension
Other Intervention Name(s)
Loteprednol etabonate
Intervention Type
Drug
Intervention Name(s)
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Secondary Outcome Measure Information:
Title
Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)
Description
Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. 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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Title
Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)
Description
Comparison of ocular discomfort scores 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 using 3-day mean scores.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Title
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) - Day 4
Title
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup
Description
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, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) - Day 3
Title
Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)
Description
Comparison of mean eye dryness 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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)
Description
Comparison of mean eye dryness 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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Title
Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) - Day 1
Title
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)
Description
Comparison of mean ocular discomfort frequency 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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)
Description
Comparison of mean ocular discomfort frequency 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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Title
Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Description
Comparison of mean corneal fluorescein staining in the study eye 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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Description
Comparison of mean nasal corneal fluorescein staining in the study eye 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.
Time Frame
Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UAB School of Optometry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0010
Country
United States
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Milton M. Hom, OD, FAAO
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Family Eye Care Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Orange County Ophthalmology
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
The Gavin Herbert Eye Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92697-4375
Country
United States
Facility Name
Macy Eye Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Advanced Vision Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Arch Health Partners
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Shasta Eye Medical Group, Inc
City
Redding
State/Province
California
ZIP/Postal Code
96002
Country
United States
Facility Name
West Coast Eye Care Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Michael K Tran, M.D., Inc.
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Central Florida Eye Associates
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Shettle Eye Research, Inc
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
International Eye Associates PA
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Perez Eye Center/International Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Eye Care Centers Management, Inc. (Clayton Eye Center)
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Chicago Cornea Consultants, Ltd.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
John-Kenyon American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Cincinnati Eye Institute
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Koffler Vision Group
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Minnesota Eye Consultants, PA
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Abrams Eye Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Raymond Fong, MDPC
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
James D Branch MD
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Comprehensive Eye Care of Central Ohio
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
Facility Name
Drs. Fine, Hoffman & Sims, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Bucci Laser Vision Institute
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Facility Name
Chattanooga Eye Institute, P.C.
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Toyos Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Texan Eye, PA / Keystone Research, Ltd
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
The Cataract and Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Whitsett Vision Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
The Ocular Surface Institute (TOSI), University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
Brazosport Eye Institute
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Kozlovsky Delay & Winter Eye Consultants, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Hoopes Vision
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Regional Eye Associates
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease

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