Fuchs' Endothelial Corneal DystrophyPhase 2NCT04250207
Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
A Phase 2 study testing K-321 Solution in people with Fuchs' Endothelial Corneal Dystrophy, run by Kowa Research Institute, Inc. at 29 sites in 5 countries.
Trial summary
The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Corneal Dystrophy
- What is being tested?
- K-321 Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 29 sitesin 5 countries
- Study dates
- 23 Jun 2020to 27 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
United States19 sites
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
W Kellogg Eye Center
Ann Arbor, Michigan, 48105
Vantage EyeCare, LLC
Bala-Cynwyd, Pennsylvania, 19004
Minnesota Eye Consultants
Bloomington, Minnesota, 55431
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Gorovoy MD Eye Specialists
Fort Myers, Florida, 33907
UF Health Eye Center
Gainesville, Florida, 32605
Chicago Cornea Consultants Ltd
Hoffman Estates, Illinois, 60169
Price Vision Group
Indianapolis, Indiana, 46260
Jules Stein Eye Institute
Los Angeles, California, 90095
NY Langone Health
New York, New York, 10017
Arbor Centers For Eyecare
Orland Park, Illinois, 60467
Byers Eye Institute at Stanford
Palo Alto, California, 94304
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
Devers Eye Institute
Portland, Oregon, 97210
Casey Eye Institute - OHSU
Portland, Oregon, 97239
UC Davis Eye Center
Sacramento, California, 95817
Sacramento Eye Consultants
Sacramento, California, 98515
Spain4 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Instituto de Microcirugia Ocular
Barcelona, 8035
Hospital La Arruzafa
Córdoba, 14012
Instituto Ophthalmologic Fernandez Vega
Oviedo, Principality of Asturias, 33012
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Sydney Eye Hospital
Sydney, New South Wales, 2000
Denmark2 sites
Aarhus Universitetshospital
Aarhus, 8200
Rigshospitalet - Glostrup
Glostrup Municipality, Capital, 2600
Germany2 sites
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Universität des Saarlandes
Homburg, Saarland, 66421
About this study
Official title: A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12 Week, Phase 2 Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Patients With Fuchs Endothelial Corneal Dystrophy
The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.
- Conditions
- Fuchs' Endothelial Corneal Dystrophy
- Being tested
- K-321 Solution, Placebo Solution
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-321 SolutionDrug
K-321 solution drops
Placebo SolutionDrug
Placebo solution drops for K-321
| Study group | Role | What they receive |
|---|---|---|
| K-321 QID | Experimental | K-321 Ophthalmic Solution Dose A Receives: Drug: K-321 Solution |
| K-321 BID | Experimental | K-321 Ophthalmic Solution Dose B Receives: Drug: K-321 Solution; Drug: Placebo Solution |
| Placebo | Placebo comparator | Vehicle Solution Dose Receives: Drug: Placebo Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Corneal Endothelial Cell Density (ECD) at Week 12
Change in Central ECD at week 12
Measured: Baseline to Week 12
Secondary outcomes (9)
Central Corneal ECD From Baseline to Each Subsequent Visit
Measured: Baseline to Week 52
Change From Baseline in Central Corneal Thickness
Measured: Baseline to Week 52
Time to Achievement of no Corneal Oedema of Study Eye
Measured: Baseline to Week 52
Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit
Measured: Baseline to Week 52
Time to Achieve Central Corneal ECD 700 Cells/mm2 or More
Measured: Up to 52 Weeks
Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness
Measured: Baseline up to 52 Weeks
Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit
Measured: Baseline to Week 52
Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness
Measured: Baseline up to Week 52
Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start23 Jun 2020
- Primary completion22 Sep 2021
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fuchs' Endothelial Corneal DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shona Pendse, MD, MMSc, Study chair, Kowa Pharma Development Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250207
- Sponsor's protocol ID
- K-321-201
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2020
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12 Week, Phase 2 Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Patients With Fuchs Endothelial Corneal Dystrophy
- ClinicalTrials.gov ID
- NCT04250207
- Acronym / sponsor ID
- K-321-201
- Conditions
- Fuchs' Endothelial Corneal Dystrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| K-321 QID | Experimental | Drug: K-321 SolutionK-321 Ophthalmic Solution Dose A |
| K-321 BID | Experimental | Drug: K-321 Solution, Drug: Placebo SolutionK-321 Ophthalmic Solution Dose B |
| Placebo | Placebo comparator | Drug: Placebo SolutionVehicle Solution Dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-321 SolutionK-321 solution drops | Drug | K-321 BID, K-321 QID |
| Placebo SolutionPlacebo solution drops for K-321 | Drug | K-321 BID, Placebo |
Primary outcome
Central Corneal Endothelial Cell Density (ECD) at Week 12
Time frame: Baseline to Week 12
Change in Central ECD at week 12
9 secondary outcomes
Central Corneal ECD From Baseline to Each Subsequent Visit
Time frame: Baseline to Week 52
Change From Baseline in Central Corneal Thickness
Time frame: Baseline to Week 52
Time to Achievement of no Corneal Oedema of Study Eye
Time frame: Baseline to Week 52
Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit
Time frame: Baseline to Week 52
Time to Achieve Central Corneal ECD 700 Cells/mm2 or More
Time frame: Up to 52 Weeks
Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness
Time frame: Baseline up to 52 Weeks
Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit
Time frame: Baseline to Week 52
Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness
Time frame: Baseline up to Week 52
Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit
Time frame: Baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shona Pendse, MD, MMSc study chair
Kowa Pharma Development Co.
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-321 Solution in people with Fuchs' Endothelial Corneal Dystrophy, run by Kowa Research Institute, Inc. at 29 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Spain, Australia, Denmark, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Corneal Endothelial Cell Density (ECD) at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.