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Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (STRIDE 1)

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, 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.

Sites / Locations

  • Cornea and Cataract Consultants of Arizona
  • Schwartz Laser Eye Center
  • Eyecare Arkansas, P.A.
  • Little Rock Eye Clinic, LLP
  • Sall Research Medical Center
  • Orange County Ophthalmology Medical Group
  • United Medical Research Institute
  • North Valley Eye Medical Group
  • Montebello Medical Center, Inc.
  • LoBue Laser and Eye Medical Center
  • Eye Research Foundation
  • Pendleton Eye Center
  • North Bay Eye Associates, Inc.
  • Martel Eye Medical Group
  • Sacramento Eye Consultants
  • Eye Center of Northern Colorado, PC
  • Corneal Consultants of Colorado
  • The Eye Center of Southern CT, P.C.
  • Florida Eye Microsurgical Institute, Inc.
  • Eye Associates of Fort Myers
  • Shettle Eye Research, Inc.
  • Atlantic Eye Center
  • The Eye Center of North Florida
  • Dixon Eye Care
  • Jacksoneye, S. C.
  • Midwest Cornea Associates, LLC
  • Stiles EyeCare Excellence and Glaucoma Institute
  • Clinical Eye Research of Boston
  • Chu Vision Institute
  • Lifelong Vision Foundation at Pepose Vision Institute
  • Ophthalmology Associates
  • Ophthalmology Consultants, Ltd.
  • Wellish Vision Institute
  • Matossian Eye Associates
  • Rochester Ophthalmological Group, PC
  • Cornea Consultants of Albany
  • South Shore Eye Center, LLP
  • Mundorf Eye Center
  • Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
  • Eyecare Center
  • Bergstrom Eye Research
  • Abrams Eye Center
  • Opthalamic Surgeons & Consultants of Ohio
  • Apex Eye
  • Roseburg Research Associates, LLC
  • Scott & Christie and Associates, PC
  • Conestoga Eye
  • UPMC Eye Center
  • Black Hills Regional Eye Institute
  • Total Eye Care, PA
  • Hill Country Eye Center
  • Houston Eye Associates
  • The Eye Clinic of Texas, Affiliate of Houston Eye Associates
  • Lake Travis Eye and Laser Center
  • Eye Clinics of South Texas
  • R and R Eye Research, LLC
  • Keystone Research - Medical Center Ophthalmology Associates
  • Tanner Clinic
  • See Clearly Vision
  • Virginia Eye Consultants

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 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 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.
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.
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.

Secondary Outcome Measures

Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)
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.
Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at 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 From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)
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 the Mean of the Scores to Baseline/Visit 2 (Day 1)
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 Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) 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.
Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)
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 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) 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.
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
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)
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

Full Information

First Posted
June 21, 2016
Last Updated
January 19, 2021
Sponsor
Kala Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02813265
Brief Title
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Acronym
STRIDE 1
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
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 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
918 (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 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.
Time Frame
Baseline/Visit 2 (Day 1) and to 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 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) and to Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Title
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
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, in a sub-group of participants with more severe ocular discomfort at baseline.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary Outcome Measure Information:
Title
Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Title
Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Title
Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Title
Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)
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) and to Visit 3 (Day 8)
Title
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.
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) and to Visit 3 (Day 8)
Title
Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)
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) and to Visit 3 (Day 8)
Title
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
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, in a sub-group of participants with more severe ocular discomfort at baseline.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Title
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
Description
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.
Time Frame
Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Title
Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)
Description
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
Time Frame
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, 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.
Facility Information:
Facility Name
Cornea and Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Schwartz Laser Eye Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Eyecare Arkansas, P.A.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Little Rock Eye Clinic, LLP
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Orange County Ophthalmology Medical Group
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Montebello Medical Center, Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
LoBue Laser and Eye Medical Center
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pendleton Eye Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Sacramento Eye Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Eye Center of Northern Colorado, PC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Corneal Consultants of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
The Eye Center of Southern CT, P.C.
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Florida Eye Microsurgical Institute, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Shettle Eye Research, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Atlantic Eye Center
City
Palm Coast
State/Province
Florida
ZIP/Postal Code
32137
Country
United States
Facility Name
The Eye Center of North Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Dixon Eye Care
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
Jacksoneye, S. C.
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Midwest Cornea Associates, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Stiles EyeCare Excellence and Glaucoma Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Clinical Eye Research of Boston
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Lifelong Vision Foundation at Pepose Vision Institute
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ophthalmology Consultants, Ltd.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Wellish Vision Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Matossian Eye Associates
City
Pennington
State/Province
New Jersey
ZIP/Postal Code
08534
Country
United States
Facility Name
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Cornea Consultants of Albany
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
South Shore Eye Center, LLP
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Mundorf Eye Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Eyecare Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Bergstrom Eye Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Opthalamic Surgeons & Consultants of Ohio
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Apex Eye
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Roseburg Research Associates, LLC
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97471
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
Conestoga Eye
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Hill Country Eye Center
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Lake Travis Eye and Laser Center
City
Leander
State/Province
Texas
ZIP/Postal Code
78641
Country
United States
Facility Name
Eye Clinics of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
R and R Eye Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Keystone Research - Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Tanner Clinic
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
See Clearly Vision
City
McLean
State/Province
Virginia
ZIP/Postal Code
22102
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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