Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis

Phase 2

Completed

• Conditions: Fuchs' Endothelial Corneal Dystrophy
• Interventions: Drug: K-321 Solution; Drug: Placebo Solution

• Registration Number: NCT04250207
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Study Start: 2020-06-23
• Primary Completion: 2021-09-22
• Study Completion: 2022-06-27
• Disposition First Submitted: 2022-09-20
• Results First Submitted: 2024-09-20
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-01
• Last Update Submitted: 2024-11-01
• Results First Posted: 2024-11-05
• Disposition First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K-321 BID	K-321 Solution	K-321 Ophthalmic Solution Dose B
Placebo	Placebo Solution	Vehicle Solution Dose
K-321 QID	K-321 Solution	K-321 Ophthalmic Solution Dose A
K-321 BID	Placebo Solution	K-321 Ophthalmic Solution Dose B

Primary Outcome Measures

Name	Time	Method
Central Corneal Endothelial Cell Density (ECD) at Week 12	Baseline to Week 12	Change in Central ECD at week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit	Baseline to Week 52
Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness	Baseline up to Week 52
Central Corneal ECD From Baseline to Each Subsequent Visit	Baseline to Week 52
Change From Baseline in Central Corneal Thickness	Baseline to Week 52
Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit	Baseline to Week 52
Time to Achieve Central Corneal ECD 700 Cells/mm2 or More	Up to 52 Weeks
Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Baseline to Week 52
Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness	Baseline up to 52 Weeks
Time to Achievement of no Corneal Oedema of Study Eye	Baseline to Week 52

Trial Locations

Locations (29)

Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States

Byers Eye Institute at Stanford; 🇺🇸 Palo Alto, California, United States

UC Davis Eye Center; 🇺🇸 Sacramento, California, United States

Sacramento Eye Consultants; 🇺🇸 Sacramento, California, United States

Gorovoy MD Eye Specialists; 🇺🇸 Fort Myers, Florida, United States

UF Health Eye Center; 🇺🇸 Gainesville, Florida, United States

Chicago Cornea Consultants Ltd; 🇺🇸 Hoffman Estates, Illinois, United States

Arbor Centers For Eyecare; 🇺🇸 Orland Park, Illinois, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

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