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
331
Change in Central Corneal Endothelial Cell Density (ECD) at Week 12
Corneal ECD measurement captured by specular microscopy
Time frame: Baseline to Week 12
Change in Central Corneal ECD
Corneal ECD measurement captured by specular microscopy
Time frame: Baseline to Week 26
Change in Peripheral Corneal ECD
Corneal ECD measurement captured by specular microscopy
Time frame: Baseline to Week 26
Change in Corneal Thickness
measured in micrometers by contact ultrasound pachymetry, or optical pachymetry
Time frame: Baseline to Week 26
Change in corneal edema
assessed as either being present or absent during slit-lamp examination
Time frame: Baseline to Week 26
Change in Best-Corrected Visual Acuity (BCVA)
Measured by ETDRS scale
Time frame: Baseline to Week 26
Change in Vision-related quality of life
Visual Functioning Questionnarie-25 (VFQ 25, Version 2000)
Time frame: Baseline to Week 26
Number of Participants with Adverse Events and Treatment Emergent Adverse Events
Coded using the MedDRA dictionary (the most recent version, ver. 24.1 or later)
Time frame: Baseline to Week 26
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Safety Assessment with Slit-lamp Biomicroscopy and Dilated Fundoscopy
Graded as Normal or Abnormal
Time frame: Baseline to Week 26
Safety Assessment of Intraocular Pressure (IOP)
Results will be recorded in mm Hg
Time frame: Baseline to Week 26