A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
107
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 ECD 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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