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

Dry Eye Syndromes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819284
• Other study ID #: KPI-121-C-007
• Status: Completed
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: November 2020
• 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: 909
• Est. completion date: September 2017
• Est. primary completion date: September 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, 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	Sall Research Medical Center	Artesia	California
United States	Texan Eye, PA / Keystone Research, Ltd	Austin	Texas
United States	Milton M. Hom, OD, FAAO	Azusa	California
United States	UAB School of Optometry	Birmingham	Alabama
United States	Minnesota Eye Consultants, PA	Bloomington	Minnesota
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Hernando Eye Institute	Brooksville	Florida
United States	Family Eye Care Center	Campbell	California
United States	Arizona Eye Center	Chandler	Arizona
United States	Chattanooga Eye Institute, P.C.	Chattanooga	Tennessee
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Hoopes Vision	Draper	Utah
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	The Cataract and Glaucoma Center	El Paso	Texas
United States	Drs. Fine, Hoffman & Sims, LLC	Eugene	Oregon
United States	Orange County Ophthalmology	Garden Grove	California
United States	Lugene Eye Institute	Glendale	California
United States	Cornerstone Eye Care	High Point	North Carolina
United States	Chicago Cornea Consultants, Ltd.	Hoffman Estates	Illinois
United States	Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center	Houston	Texas
United States	Houston Eye Associates	Houston	Texas
United States	The Ocular Surface Institute (TOSI), University of Houston	Houston	Texas
United States	Whitsett Vision Group	Houston	Texas
United States	Price Vision Group	Indianapolis	Indiana
United States	The Gavin Herbert Eye Institute	Irvine	California
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Tauber Eye Center	Kansas City	Missouri
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Brazosport Eye Institute	Lake Jackson	Texas
United States	Central Florida Eye Associates	Lakeland	Florida
United States	Shettle Eye Research, Inc	Largo	Florida
United States	Abrams Eye Institute	Las Vegas	Nevada
United States	Koffler Vision Group	Lexington	Kentucky
United States	Advanced Vision Care	Los Angeles	California
United States	Macy Eye Center	Los Angeles	California
United States	Taustine Eye Center	Louisville	Kentucky
United States	The Eye Care Institute	Louisville	Kentucky
United States	Total Eye Care, PA	Memphis	Tennessee
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Regional Eye Associates	Morgantown	West Virginia
United States	Eye Care Centers Management, Inc. (Clayton Eye Center)	Morrow	Georgia
United States	Toyos Clinic	Nashville	Tennessee
United States	John-Kenyon American Eye Institute	New Albany	Indiana
United States	Raymond Fong, MDPC	New York	New York
United States	Eye Research Foundation	Newport Beach	California
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	International Eye Associates PA	Ormond Beach	Florida
United States	Arch Health Partners	Poway	California
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Shasta Eye Medical Group, Inc	Redding	California
United States	Ophthalmic Consultants of Long Island	Rockville Centre	New York
United States	Tekwani Vision Center	Saint Louis	Missouri
United States	Kozlovsky Delay & Winter Eye Consultants, LLC	San Antonio	Texas
United States	West Coast Eye Care Associates	San Diego	California
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Perez Eye Center/International Research Center	Tampa	Florida
United States	Wolstan & Goldberg Eye Associates	Torrance	California
United States	Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC	Washington	Missouri
United States	Comprehensive Eye Care of Central Ohio	Westerville	Ohio
United States	Michael K Tran, M.D., Inc.	Westminster	California
United States	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania
United States	James D Branch MD	Winston-Salem	North Carolina

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 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)
Primary	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	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.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Secondary	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.	Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Secondary	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.	Baseline/Visit 2 (Day 1) - Day 4
Secondary	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.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Secondary	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.	Baseline/Visit 2 (Day 1) - Day 3
Secondary	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.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Secondary	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.	Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Secondary	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.	Baseline/Visit 2 (Day 1) - Day 1
Secondary	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.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Secondary	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.	Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Secondary	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.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Secondary	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.	Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)