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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)

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ClinicalTrials.gov Identifier: NCT05826353
Recruitment Status : Recruiting
First Posted : April 24, 2023
Last Update Posted : January 25, 2024
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : May 11, 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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 Name: 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




Primary Outcome Measures :
  1. Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks [ Time Frame: Baseline to Week 12 ]

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 the Clinical Study Protocol.

Exclusion Criteria:

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

    1. is pregnant or lactating/breastfeeding, or
    2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05826353


Contacts
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Contact: Director, Clinical Operations 919-433-1621 StudyRecruitment@KowaUS.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
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Study Chair: Shona Pendse, MD, MMSc Kowa Pharma Development Co.
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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT05826353    
Other Study ID Numbers: K-321-303
First Posted: April 24, 2023    Key Record Dates
Last Update Posted: January 25, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Corneal Dystrophies, Hereditary
Fuchs' Endothelial Dystrophy
Lens Diseases
Eye Diseases
Corneal Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn