Trial record 1 of 1 for:
KOWA 321-303
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 |
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Recruitment Status :
Recruiting
First Posted : April 24, 2023
Last Update Posted : April 18, 2024
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Sponsor:
Kowa Research Institute, Inc.
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
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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 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 : | June 2024 |
| Estimated Study Completion Date : | January 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Fuchs endothelial dystrophy
MedlinePlus related topics:
Cataract
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: Ripasudil
K-321 ophthalmic solution
Other Name: K-321 |
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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
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Drug: Placebo
Placebo ophthalmic solution |
Primary Outcome Measures :
- 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 :
- 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 ]
- 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 ]
- 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:
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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.
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
| Contact: Director, Clinical Operations | 919-433-1621 | StudyRecruitment@KowaUS.com |
Locations
Show 47 study locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
| Study Chair: | Shona Pendse, MD, MMSc | Kowa Pharma Development Co. |
| 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: | April 18, 2024 |
| Last Verified: | April 2024 |
| 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 |