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

Kowa

Status and phase: Completed; Phase 2

Conditions: Fuchs' Endothelial Corneal Dystrophy

Treatments: Drug: Placebo Solution; Drug: K-321 Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04250207

K-321-201

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 3 patient groups, including a placebo group

K-321 QID

Experimental group

Description:

K-321 Ophthalmic Solution Dose A

Treatment:

Drug: K-321 Solution

K-321 BID

Experimental group

Description:

K-321 Ophthalmic Solution Dose B

Treatment:

Drug: K-321 Solution

Drug: Placebo Solution

Placebo

Placebo Comparator group

Description:

Vehicle Solution Dose

Treatment:

Drug: Placebo Solution