The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
330
Change From Baseline in Central Corneal Endothelial Cell Density (ECD) at Week 12
Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
Time frame: Baseline to Week 12
Change From Baseline in Central Corneal ECD at Each Visit
Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
Time frame: Baseline to Week 26
Change From Baseline in Peripheral Corneal ECD (Nasal)
Peripheral corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
Time frame: Baseline to Week 26
Change From Baseline in Peripheral Corneal ECD (Temporal)
Corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm².
Time frame: Baseline to Week 26
Change From Baseline in Central Corneal Thickness
Corneal thickness measured by contact ultrasound pachymetry or optical pachymetry recorded in micrometers (μm)
Time frame: Baseline to Week 26
Number of Subjects With No Evidence of Corneal Edema
Corneal edema of the study eye, evaluated by slit-lamp examination, recorded as present or absent, and categorized by anatomical location.
Time frame: Baseline to Week 26
Change From Baseline in Best-Corrected Visual Acuity (BCVA)
Best-corrected visual acuity (BCVA) of the study eye, assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
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Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Inland Eye Specialists
Hemet, California, United States
United Medical Research Institute
Inglewood, California, United States
Alvarado Eye Associates
La Mesa, California, United States
SoCal Eye Physicians and Associates
Long Beach, California, United States
Visionary Research Institute
Newport Beach, California, United States
Pendleton Eye Center
Oceanside, California, United States
North Bay Eye Associates
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
...and 35 more locations
Time frame: Baseline to Week 26
Change From Baseline in VFQ-25 (Overall)
Visual Function assessed using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25), a patient-reported measure of vision-related functioning and quality of life. Scores range from 0 to 100, with higher scores indicating better visual function and lower scores indicating worse visual function. The total composite score is derived from multiple subscales using the standard VFQ-25 scoring method.
Time frame: Baseline to Week 26
Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva)
Shift in slit-lamp biomicroscopy findings of the study eye categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. \- Baseline to Post-Baseline Shift
Time frame: Baseline to Week 26
Shifts in Slit-lamp Biomicroscopy (Cornea)
Shift in slit-lamp biomicroscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. Baseline to Post-Baseline Shift
Time frame: Baseline to Week 26
Shifts in Dilated Fundoscopy (Central Retina)
Shift in dilated fundoscopy findings of the study eye, categorized as Normal, Abnormal - Not Clinically Significant (NCS), or Abnormal - Clinically Significant (CS), reflecting changes relative to baseline. Baseline to Post-Baseline Shift
Time frame: Baseline to Week 26
Change From Baseline in Intraocular Pressure (mmHg)
Intraocular pressure (IOP) of the study eye, measured using either a contact or non-contact tonometer, and recorded in millimeters of mercury (mm Hg).
Time frame: Baseline to Week 26