Corneal Edema After Cataract Surgery
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery
Interventions
DRUGRipasudil
K-321 ophthalmic solution
DRUGPlacebo
Placebo ophthalmic solution
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 18 years old at the screening visit (Visit 1). * Is planning to undergo cataract surgery in the study eye and has had cataract surgery at Visit 2. * Can understand the written informed consent, provides signed written informed consent, and agrees to comply with protocol requirements before any study-specific assessment is performed. * Meet all other inclusion criteria outlined in clinical study protocol.
Exclusion criteria
* Is a female subject of childbearing potential and any of the following is true: 1. is pregnant or lactating/breastfeeding, or 2. has experienced menarche and is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not willing to practice an effective method of birth control during the study period as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy). 3. has a positive urine pregnancy test result at Visit 2 before cataract surgery. * Had intraocular surgery (non-laser surgery) in the study eye within 6 months of Visit 1. * Had intraocular laser surgery in the study eye within 3 months of Visit 1. * Meet any other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Corneal Endothelial Cell Density (ECD) at Week 12 | Baseline to Week 12 | Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm². |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shifts in Slit-lamp Biomicroscopy (Cornea) | Baseline to Week 26 | 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 |
| Shifts in Dilated Fundoscopy (Central Retina) | Baseline to Week 26 | 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 |
| Change From Baseline in Intraocular Pressure (mmHg) | Baseline to Week 26 | Intraocular pressure (IOP) of the study eye, measured using either a contact or non-contact tonometer, and recorded in millimeters of mercury (mm Hg). |
| Change From Baseline in Central Corneal ECD at Each Visit | Baseline to Week 26 | Central corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm². |
| Change From Baseline in Peripheral Corneal ECD (Nasal) | Baseline to Week 26 | Peripheral corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm². |
| Change From Baseline in Peripheral Corneal ECD (Temporal) | Baseline to Week 26 | Corneal endothelial cell density (ECD) of the study eye, measured by specular microscopy, expressed as cells/mm². |
| Change From Baseline in Central Corneal Thickness | Baseline to Week 26 | Corneal thickness measured by contact ultrasound pachymetry or optical pachymetry recorded in micrometers (μm) |
| Number of Subjects With No Evidence of Corneal Edema | Baseline to Week 26 | Corneal edema of the study eye, evaluated by slit-lamp examination, recorded as present or absent, and categorized by anatomical location. |
| Change From Baseline in Best-Corrected Visual Acuity (BCVA) | Baseline to Week 26 | Best-corrected visual acuity (BCVA) of the study eye, assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. |
| Shifts in Slit-lamp Biomicroscopy (Bulbar Conjunctiva) | Baseline to Week 26 | 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 |
| Change From Baseline in VFQ-25 (Overall) | Baseline to Week 26 | 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. |
Countries
Puerto Rico, United States
Contacts
STUDY_CHAIRShona Pendse, MD, MMSc
Kowa Pharma Development Co.
Participant flow
Pre-assignment details
Prior to assignment to treatment groups, participants provided informed consent and underwent preliminary screening to determine eligibility. Following preliminary confirmation, participants who were determined to be eligible after having cataract surgery, were assigned to one of four treatment groups.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 124 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 213 | 0 / 115 | 0 / 201 | 0 / 110 | 1 / 65 | 0 / 34 |
| other Total, other adverse events | 17 / 213 | 11 / 115 | 3 / 201 | 3 / 110 | 1 / 65 | 0 / 34 |
| serious Total, serious adverse events | 6 / 213 | 2 / 115 | 1 / 201 | 2 / 110 | 2 / 65 | 0 / 34 |
Outcome results
None listed