Clinical trial NCT04250207: Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
Official title: A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12 Week, Phase 2 Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Patients With Fuchs Endothelial Corneal Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fuchs' Endothelial Corneal Dystrophy
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.


Eligibility criteria: Inclusion Criteria:

* Is at least 18 years old at the screening visit (Visit 1).
* Has a diagnosis of FECD at Visit 1.
* Meet all other inclusion criteria outlined in clinical study protocol.

Exclusion Criteria:

* Has a study eye with a history of cataract surgery within 90 days of Visit 1.
* Has a study eye with a history of any previous ocular surgery other than for cataract.
* Meet any other exclusion criteria outlined in clinical study protocol.

Primary outcomes:
measure: Central Corneal Endothelial Cell Density (ECD) at Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Central Corneal ECD From Baseline to Each Subsequent Visit
timeFrame: Baseline to Week 52
measure: Change From Baseline in Central Corneal Thickness
timeFrame: Baseline to Week 52
measure: Time to Achievement of no Corneal Oedema of Study Eye
timeFrame: Baseline to Week 52
measure: Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit
timeFrame: Baseline to Week 52
measure: Time to Achieve Central Corneal ECD 700 Cells/mm2 or More
timeFrame: Up to 52 Weeks
measure: Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness
timeFrame: Baseline up to 52 Weeks
measure: Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit
timeFrame: Baseline to Week 52
measure: Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness
timeFrame: Baseline up to Week 52
measure: Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford
state: California
city: Sacramento
country: United States
facility: UC Davis Eye Center
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants
state: California
city: Fort Myers
country: United States
facility: Gorovoy MD Eye Specialists
state: Florida
city: Gainesville
country: United States
facility: UF Health Eye Center
state: Florida
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants Ltd
state: Illinois
city: Orland Park
country: United States
facility: Arbor Centers For Eyecare
state: Illinois
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Ann Arbor
country: United States
facility: W Kellogg Eye Center
state: Michigan
city: Bloomington
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: New York
country: United States
facility: NY Langone Health
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Portland
country: United States
facility: Casey Eye Institute - OHSU
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Vantage EyeCare, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Glostrup
country: Denmark
facility: Rigshospitalet - Glostrup
state: Capital
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Homburg
country: Germany
facility: Universität des Saarlandes
state: Saarland
city: Oviedo
country: Spain
facility: Instituto Ophthalmologic Fernandez Vega
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Instituto de Microcirugia Ocular
city: Córdoba
country: Spain
facility: Hospital La Arruzafa
Study officials:
affiliation: Kowa Pharma Development Co.
name: Shona Pendse, MD, MMSc
role: STUDY_CHAIR
References: