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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02819284
Other study ID # KPI-121-C-007
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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)
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