Safety and Efficacy of KPI-121 in Subjects With DED

Kerato Conjunctivitis Sicca Clinical Trial

— STRIDE 3  

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 (STRIDE 3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616899
• Other study ID #: KPI-121-C-011
• Status: Completed
• Phase: Phase 3
• Start date: July 10, 2018
• Est. completion date: February 5, 2020

Study information

• Verified date: February 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: 901
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• 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

• Conjunctivitis
• Dry Eye Syndromes
• Kerato Conjunctivitis Sicca
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• KPI-121 Ophthalmic Suspension
KPI-121 Ophthalmic Suspension
• Vehicle
Vehicle for KPI-121 0.25% ophthalmic suspension

Locations

Country	Name	City	State
United States	Investigator #264	Asheville	North Carolina
United States	Investigator #188	Austin	Texas
United States	Investigator #270	Austin	Texas
United States	Investigator #185	Azusa	California
United States	Investigator #133	Birmingham	Alabama
United States	Investigator #184	Brooksville	Florida
United States	Investigator #174	Cedar Park	Texas
United States	Investigator #146	Chandler	Arizona
United States	Investigator #266	Chicago	Illinois
United States	Investigator #142	Cincinnati	Ohio
United States	Investigator #269	Cincinnati	Ohio
United States	Investigator #137	Cleveland	Ohio
United States	Investigator #224	Cranberry Township	Pennsylvania
United States	Investigator #262	Delray Beach	Florida
United States	Investigator #278	Dothan	Alabama
United States	Investigator #149	Durham	North Carolina
United States	Investigator #217	Durham	North Carolina
United States	Investigator #140	El Paso	Texas
United States	Investigator #279	Fort Myers	Florida
United States	Investigator #143	Garden Grove	California
United States	Investigator #147	Glendale	California
United States	Investigator #272	Hemet	California
United States	Investigator #281	Henderson	Nevada
United States	Investigator #102	High Point	North Carolina
United States	Investigator #187	Hoffman Estates	Illinois
United States	Investigator #124	Houston	Texas
United States	Investigator #259	Houston	Texas
United States	Investigator #128	Indianapolis	Indiana
United States	Investigator #250	Indianapolis	Indiana
United States	Investigator #155	Inglewood	California
United States	Investigator #265	Jacksonville	Florida
United States	Investigator #267	Kansas City	Missouri
United States	Investigator #156	Kingston	Pennsylvania
United States	Investigator #151	Lake Villa	Illinois
United States	Investigator #175	Lakeway	Texas
United States	Investigator #200	Lancaster	Pennsylvania
United States	Investigator #157	Largo	Florida
United States	Investigator #138	Las Vegas	Nevada
United States	Investigator #263	Las Vegas	Nevada
United States	Investigator #275	Las Vegas	Nevada
United States	Investigator #222	Layton	Utah
United States	Investigator #182	League City	Texas
United States	Investigator #191	League City	Texas
United States	Investigator #274	Lexington	Kentucky
United States	Investigator #218	Littleton	Colorado
United States	Investigator #273	Long Beach	California
United States	Investigator #168	Louisville	Kentucky
United States	Investigator #195	Louisville	Kentucky
United States	Investigator #171	Mason	Ohio
United States	Investigator #127	Memphis	Tennessee
United States	Investigator #130	Mission Hills	California
United States	Investigator #136	Morrow	Georgia
United States	Investigator #247	Murrieta	California
United States	Investigator #125	New Albany	Indiana
United States	Investigator #105	New York	New York
United States	Investigator #215	Newport Beach	California
United States	Investigator #119	Norfolk	Virginia
United States	Investigator #148	Phoenix	Arizona
United States	Investigator #280	Prescott	Arizona
United States	Investigator #163	Raleigh	North Carolina
United States	Site #111	Rancho Cordova	California
United States	Investigator #240	Rapid City	South Dakota
United States	Investigator #108	Rochester	New York
United States	Investigator #268	Roswell	Georgia
United States	Investigator #106	Saint Louis	Missouri
United States	Investigator #123	Saint Louis	Missouri
United States	Investigator #126	Saint Louis	Missouri
United States	Investigator #176	San Antonio	Texas
United States	Investigator #186	San Antonio	Texas
United States	Investigator #258	San Antonio	Texas
United States	Site #177	San Antonio	Texas
United States	Investigator #271	Santa Ana	California
United States	Investigator #282	Southern Pines	North Carolina
United States	Investigator #276	Sun City	Arizona
United States	Investigator #189	Tampa	Florida
United States	Investigator #107	Torrance	California
United States	Investigator #132	Wantagh	New York
United States	Investigator #131	Washington	Missouri
United States	Investigator #277	West Mifflin	Pennsylvania
United States	Investigator #213	Westminster	California
United States	Investigator #219	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 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) 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 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)
Secondary	Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor	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 From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8)	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) to Visit 3 (Day 8)
Secondary	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) to Visit 4 (Day 15)
Secondary	Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean	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) to Visit 4 (Day 15)