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

Dry Eye Syndromes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813265
• Other study ID #: KPI-121-C-006
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: October 2017

Study information

• Verified date: January 2021
• Source: Kala Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 918
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• KPI-121 0.25% Ophthalmic Suspension

• Vehicle of KPI-121 0.25% Ophthalmic Suspension

Locations

Country	Name	City	State
United States	Dixon Eye Care	Albany	Georgia
United States	Sall Research Medical Center	Artesia	California
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Florida Eye Microsurgical Institute, Inc.	Boynton Beach	Florida
United States	Hill Country Eye Center	Cedar Park	Texas
United States	Mundorf Eye Center	Charlotte	North Carolina
United States	Lifelong Vision Foundation at Pepose Vision Institute	Chesterfield	Missouri
United States	Abrams Eye Center	Cleveland	Ohio
United States	Opthalamic Surgeons & Consultants of Ohio	Columbus	Ohio
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat	Durham	North Carolina
United States	Bergstrom Eye Research	Fargo	North Dakota
United States	Eye Center of Northern Colorado, PC	Fort Collins	Colorado
United States	Eye Associates of Fort Myers	Fort Myers	Florida
United States	Orange County Ophthalmology Medical Group	Garden Grove	California
United States	The Eye Center of Southern CT, P.C.	Hamden	Connecticut
United States	Houston Eye Associates	Houston	Texas
United States	Midwest Cornea Associates, LLC	Indianapolis	Indiana
United States	United Medical Research Institute	Inglewood	California
United States	Jacksoneye, S. C.	Lake Villa	Illinois
United States	Conestoga Eye	Lancaster	Pennsylvania
United States	Shettle Eye Research, Inc.	Largo	Florida
United States	Wellish Vision Institute	Las Vegas	Nevada
United States	Tanner Clinic	Layton	Utah
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	Eyecare Arkansas, P.A.	Little Rock	Arkansas
United States	Little Rock Eye Clinic, LLP	Little Rock	Arkansas
United States	Corneal Consultants of Colorado	Littleton	Colorado
United States	Apex Eye	Mason	Ohio
United States	See Clearly Vision	McLean	Virginia
United States	Total Eye Care, PA	Memphis	Tennessee
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Montebello Medical Center, Inc.	Montebello	California
United States	LoBue Laser and Eye Medical Center	Murrieta	California
United States	Eye Research Foundation	Newport Beach	California
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Pendleton Eye Center	Oceanside	California
United States	Stiles EyeCare Excellence and Glaucoma Institute	Overland Park	Kansas
United States	Atlantic Eye Center	Palm Coast	Florida
United States	The Eye Center of North Florida	Panama City	Florida
United States	Matossian Eye Associates	Pennington	New Jersey
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona
United States	UPMC Eye Center	Pittsburgh	Pennsylvania
United States	Eyecare Center	Raleigh	North Carolina
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Rochester Ophthalmological Group, PC	Rochester	New York
United States	Roseburg Research Associates, LLC	Roseburg	Oregon
United States	Sacramento Eye Consultants	Sacramento	California
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	Ophthalmology Consultants, Ltd.	Saint Louis	Missouri
United States	Eye Clinics of South Texas	San Antonio	Texas
United States	Keystone Research - Medical Center Ophthalmology Associates	San Antonio	Texas
United States	R and R Eye Research, LLC	San Antonio	Texas
United States	Schwartz Laser Eye Center	Scottsdale	Arizona
United States	Cornea Consultants of Albany	Slingerlands	New York
United States	South Shore Eye Center, LLP	Wantagh	New York
United States	Clinical Eye Research of Boston	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Kala Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary	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.	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary	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.	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary	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.	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Secondary	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.	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Secondary	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.	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Secondary	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.	Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8)
Secondary	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.	Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Secondary	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	Visit 4 (Day 15)