A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

Sponsor

Kowa Research Institute, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05826353

Collaborator

(none)

100

Enrollment

Arms

21.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.

Condition or Disease	Intervention/Treatment	Phase
Fuchs Endothelial Corneal Dystrophy	Drug: Ripasudil Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: K-321 K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase	Drug: Ripasudil K-321 ophthalmic solution Other Names: K-321
Placebo Comparator: Placebo Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase	Drug: Placebo Placebo ophthalmic solution

Arm

Intervention/Treatment

Experimental: K-321

K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Drug: Ripasudil

K-321 ophthalmic solution

Other Names:

K-321

Placebo Comparator: Placebo

Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Drug: Placebo

Placebo ophthalmic solution

Outcome Measures

Primary Outcome Measures

Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks [Baseline to Week 12]

Secondary Outcome Measures

Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks [Baseline to Week 12]
Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks [Baseline to Week 12]
Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12 [Week 12]
Central corneal endothelial cell images will be captured by non-contact specular microscopy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 the Clinical Study Protocol.

Exclusion Criteria:

Is a female subject of childbearing potential and any of the following is true:

is pregnant or lactating/breastfeeding, or
is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy)

Meet any other exclusion criteria outlined in the Clinical Study Protocol.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kowa Research Institute, Inc.

Investigators

Study Chair: Shona Pendse, MD, MMSc, Kowa Pharma Development Co.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kowa Research Institute, Inc.

ClinicalTrials.gov Identifier:

NCT05826353

Other Study ID Numbers:

K-321-303

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Corneal Dystrophies, Hereditary

Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Apr 24, 2023