A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
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 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
Central corneal endothelial cell images will be captured by non-contact specular microscopy.
Time frame: Week 12
Time to achievement of no corneal edema during the first 12 weeks
Time frame: Baseline to Week 12
Time to exceed in BCVA pre-DSO ETDRS letter score during the first 12 weeks
Time frame: Baseline to Week 12
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Keck Hospital of USC
Los Angeles, California, United States
Macy Eye Center
Los Angeles, California, United States
Byers Eye Institute at Stanford
Palo Alto, California, United States
Sacramento Eye Consultants
Sacramento, California, United States
Gorovoy MD Eye Specialists
Fort Myers, Florida, United States
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States
Grene Vision Group-Wichita
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
W Kellogg Eye Center
Ann Arbor, Michigan, United States
Verdier Eye Center
Grand Rapids, Michigan, United States
...and 33 more locations