A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Treatment and 14-week Extension, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery
Overview
- Phase
- Phase 3
- Intervention
- Ripasudil
- Conditions
- Corneal Edema After Cataract Surgery
- Sponsor
- Kowa Research Institute, Inc.
- Enrollment
- 331
- Locations
- 44
- Primary Endpoint
- Change in Central Corneal Endothelial Cell Density (ECD) at Week 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery
Investigators
Eligibility Criteria
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
- •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:
- •is pregnant or lactating/breastfeeding, or
- •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).
- •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
- •Had intraocular laser surgery in the study eye within 3 months of Visit
- •Meet any other exclusion criteria outlined in clinical study protocol
Arms & Interventions
Group A
Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 4 week follow-up period with no treatment.
Intervention: Ripasudil
Group B
Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 14 week follow-up period with no treatment.
Intervention: Ripasudil
Group C
Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 4 week follow-up period with no treatment.
Intervention: Placebo
Group D
Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 14 week follow-up period with no treatment.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Central Corneal Endothelial Cell Density (ECD) at Week 12
Time Frame: Baseline to Week 12
Corneal ECD measurement captured by specular microscopy
Secondary Outcomes
- Change in Best-Corrected Visual Acuity (BCVA)(Baseline to Week 26)
- Change in Vision-related quality of life(Baseline to Week 26)
- Change in Corneal Thickness(Baseline to Week 26)
- Change in corneal edema(Baseline to Week 26)
- Change in Peripheral Corneal ECD(Baseline to Week 26)
- Change in Central Corneal ECD(Baseline to Week 26)
- Number of Participants with Adverse Events and Treatment Emergent Adverse Events(Baseline to Week 26)
- Safety Assessment with Slit-lamp Biomicroscopy and Dilated Fundoscopy(Baseline to Week 26)
- Safety Assessment of Intraocular Pressure (IOP)(Baseline to Week 26)