Phase 2
N=65
Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
Fuchs' Endothelial Corneal Dystrophy
Bottom Line
View on ClinicalTrials.gov: NCT04250207 ↗Enrolled (actual)
65
Serious AEs
6.2%
Results posted
Nov 2024
Primary outcome: Primary: Central Corneal Endothelial Cell Density (ECD) at Week 12 — 530.86; 468.02; 228.05 cells/mm2 — p=0.0065
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- K-321 Solution (Drug); Placebo Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kowa Research Institute, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Corneal Endothelial Cell Density (ECD) at Week 12 |
530.86; 468.02; 228.05 | 0.0065 sig |
| SECONDARY Central Corneal ECD From Baseline to Each Subsequent Visit |
440.01; 319.06; 254.27; 0.00; 0.05; 0.05 | 0.3587 |
| SECONDARY Change From Baseline in Central Corneal Thickness |
265.57; 250.30; 319.33; 237.54; 249.14; 315.18 | 0.2434 |
| SECONDARY Time to Achievement of no Corneal Oedema of Study Eye |
35.0; 51.5; 267.0 | 0.0021 sig |
| SECONDARY Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit |
0; 0; 0; 0; 0; 0 | 0.4872 |
| SECONDARY Time to Achieve Central Corneal ECD 700 Cells/mm2 or More |
141.0; 181.0; 273.0 | 0.1209 |
| SECONDARY Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness |
0; 0; 0; 0; 0; 0 | 0.0915 |
| SECONDARY Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit |
0; 0; 0; 0; 0; 0 | 0.0093 sig |
| SECONDARY Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness |
50; 50.0; 165.0 | 0.0259 sig |
| SECONDARY Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit |
45.76; 41.48; 51.41; 39.03; 36.77; 40.97 | 0.4435 |
Summary
The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT04250207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.