K-321 Eye Drops for Fuchs' Dystrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests eye drops called K-321 (also known as Ripasudil) to determine their safety and effectiveness for people with Fuchs' Dystrophy, a condition affecting the clear layer of cells on the front of the eye. Participants will receive either K-321 or a placebo (a solution with no active medicine) to compare results. The goal is to assess whether K-321 can aid recovery after a procedure called descemetorhexis, which aims to improve vision. Suitable candidates for this trial have been diagnosed with Fuchs' Dystrophy and have not undergone cataract surgery within the last 90 days. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
The protocol does not specify whether you need to stop taking your current medications.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Ripasudil positively affects eye conditions like corneal swelling, improving key measures such as visual clarity. However, specific safety information for K-321 or its other names is not available.
The study's late phase indicates that earlier trials found the treatment safe enough to proceed. While this does not guarantee complete safety, it has been deemed tolerable in previous tests.12345Why do researchers think this study treatment might be promising for Fuchs' Dystrophy?
Unlike the standard treatments for Fuchs' dystrophy, which often involve corneal transplants or the use of hypertonic saline drops to manage symptoms, K-321 eye drops offer a novel approach. K-321 contains Ripasudil, which is known to target and inhibit Rho-associated kinase (ROCK). This mechanism helps to enhance corneal endothelial cell function and potentially delay or reverse disease progression. Researchers are excited about K-321 because it represents a non-surgical option that could improve vision and quality of life for patients by directly addressing the underlying cellular issues in the cornea.
What evidence suggests that K-321 eye drops might be an effective treatment for Fuchs' dystrophy?
Research has shown that Ripasudil, an ingredient in K-321 eye drops, may help treat Fuchs' endothelial corneal dystrophy (FECD). Studies suggest that Ripasudil, a type of ROCK inhibitor, can protect the cornea by slowing the loss of crucial cells that keep it clear. One study found that Ripasudil helped maintain corneal health after eye surgery, benefiting FECD patients. Early findings indicate that these eye drops might aid in corneal healing and improve vision for those with FECD. In this trial, participants will receive either K-321 or a placebo to evaluate Ripasudil's effectiveness as a treatment option for this condition.12678
Who Is on the Research Team?
Shona Pendse, MD, MMSc
Principal Investigator
Kowa Pharma Development Co.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Fuchs Endothelial Corneal Dystrophy (FECD) who have not had cataract surgery in the last 90 days. Women must not be pregnant, breastfeeding, or of childbearing potential unless using effective birth control or are surgically sterile/post-menopausal.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive K-321 or placebo eye drops four times daily for 12 weeks
Dose Taper
Participants undergo a gradual dose taper of the eye drops
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Ripasudil
Ripasudil is already approved in Japan for the following indications:
- Glaucoma
- Ocular hypertension
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kowa Research Institute, Inc.
Lead Sponsor