K-321 Eye Drops for Fuchs' Dystrophy

Recruiting at 52 trial locations

Overseen By Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kowa Research Institute, Inc.

Disqualifiers: Pregnancy, Breastfeeding, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

110 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing K-321 to see if it helps people with FECD recover better after cataract surgery and descemetorhexis by supporting the healing of their cornea. K-321 has shown promise in treating corneal conditions like Fuchs' Endothelial Corneal Dystrophy (FECD).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the drug K-321 Eye Drops for Fuchs' Dystrophy?

Ripasudil, a component of K-321 Eye Drops, is effective in lowering eye pressure in glaucoma and ocular hypertension by improving fluid outflow in the eye, which might suggest potential benefits for eye conditions like Fuchs' Dystrophy. ^{1 2 3 4 5}

How is the drug Ripasudil unique for treating Fuchs' Dystrophy?

Ripasudil is unique because it is a Rho-associated kinase inhibitor that may help with corneal endothelial cell function, which is relevant for Fuchs' Dystrophy, a condition affecting the corneal endothelium. Unlike other treatments, it has been shown to alter corneal endothelial cell morphology and aid in wound healing, which could be beneficial for this specific eye condition. ^{1 2 3 4 6}

Research Team

Shona Pendse, MD, MMSc

Principal Investigator

Kowa Pharma Development Co.

Eligibility Criteria

This trial is for adults over 18 with Fuchs Endothelial Corneal Dystrophy (FECD) who are undergoing cataract surgery and descemetorhexis. Participants must meet all other criteria specified in the study protocol.

Inclusion Criteria

Meet all other inclusion criteria outlined in the Clinical Study Protocol.

I have been diagnosed with Fuchs' dystrophy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive K-321 or placebo ophthalmic solution four times daily for 12 weeks

12 weeks

Dose Taper

Participants undergo a two-week gradual dose taper phase

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

38 weeks

Treatment Details

Interventions

• Placebo
• Ripasudil

Trial Overview The trial is testing K-321 eye drops to see if they're safe and effective when used after cataract surgery and descemetorhexis in patients with FECD, compared to a placebo.

Participant Groups

Group I: K-321 Experimental Treatment 1 Intervention

K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Group II: Placebo Placebo Group 1 Intervention

Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Ripasudil is already approved in Japan for the following indications:

Approved in Japan as Glanatec for:

• Glaucoma
• Ocular hypertension

Who Is Running the Clinical Trial?

Kowa Research Institute, Inc.

Lead Sponsor

Trials

46

Recruited

16,400+

Findings from Research

Ripasudil hydrochloride hydrate is an effective treatment for glaucoma and ocular hypertension, working by reducing intraocular pressure through its action on the trabecular meshwork to enhance fluid outflow.

The eye drop solution has been approved in Japan for use when other treatments are ineffective, and it may provide additional benefits when combined with other glaucoma medications, such as prostaglandin analogues and β blockers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ripasudil: first global approval. Garnock-Jones, KP.[2022]

Ripasudil hydrochloride hydrate is an effective treatment for lowering intraocular pressure (IOP) in various types of glaucoma, including primary open-angle and angle-closure glaucoma, and can be used in different treatment scenarios such as monotherapy or combination therapy.

The most common side effect is mild conjunctival hyperemia, while serious systemic adverse reactions are rare; however, patient selection is crucial, as the effectiveness of ripasudil may be reduced in patients with irreversible damage to the trabecular meshwork.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ripasudil Hydrochloride Hydrate in the Treatment of Glaucoma: Safety, Efficacy, and Patient Selection. Kusuhara, S., Nakamura, M.[2020]

Ripasudil eye drops significantly enhanced the healing of corneal endothelial cells, as shown by increased cell proliferation and regeneration in both cultured human cells and a rabbit model of corneal injury.

In the rabbit model, 91.5% of corneal endothelial cells treated with ripasudil were actively proliferating, leading to improved transparency in the corneas, indicating its potential as a treatment for corneal endothelial damage following eye surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Rho-Associated Kinase Inhibitor Eye Drop (Ripasudil) on Corneal Endothelial Wound Healing. Okumura, N., Okazaki, Y., Inoue, R., et al.[2016]

Ripasudil, a ROCK inhibitor approved for glaucoma treatment, causes transient morphological changes in the corneal endothelium, resembling guttae, without disrupting corneal function or causing cell death.

The study found no severe adverse effects from ripasudil, but physicians should recognize these guttae-like changes to prevent misdiagnosis of conditions like Fuchs endothelial corneal dystrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rho-Associated Kinase Inhibitor Eye Drop (Ripasudil) Transiently Alters the Morphology of Corneal Endothelial Cells. Okumura, N., Okazaki, Y., Inoue, R., et al.[2015]

Ripasudil hydrochloride hydrate, when used continuously in rabbit eyes, leads to structural changes such as increased intercellular space in the trabecular meshwork and ciliary body, which may enhance intraocular pressure reduction.

The treatment appears to improve both conventional and unconventional outflow pathways without causing serious side effects, indicating its potential efficacy and safety for managing intraocular pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 0.4% ripasudil hydrochloride hydrate on morphological changes in rabbit eyes. Limratchatamorn, B., Asakawa, K., Mashimo, K., et al.[2020]

Ripasudil hydrochloride hydrate, a Rho-associated kinase inhibitor, significantly reduced intraocular pressure (IOP) in patients with uveitic glaucoma, with median IOP decreasing from 23 mmHg at baseline to 16 mmHg at 1 month and 18 mmHg at 12 months.

The treatment was found to be safe, with only two mild adverse events reported, and it may be particularly effective for patients who respond well to the medication, showing a greater IOP reduction over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ripasudil, a Rho-associated kinase inhibitor, in eyes with uveitic glaucoma. Kusuhara, S., Katsuyama, A., Matsumiya, W., et al.[2018]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Ripasudil: first global approval. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Ripasudil Hydrochloride Hydrate in the Treatment of Glaucoma: Safety, Efficacy, and Patient Selection. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of the Rho-Associated Kinase Inhibitor Eye Drop (Ripasudil) on Corneal Endothelial Wound Healing. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Rho-Associated Kinase Inhibitor Eye Drop (Ripasudil) Transiently Alters the Morphology of Corneal Endothelial Cells. [2015]

5. China pubmed.ncbi.nlm.nih.gov

Effects of 0.4% ripasudil hydrochloride hydrate on morphological changes in rabbit eyes. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ripasudil, a Rho-associated kinase inhibitor, in eyes with uveitic glaucoma. [2018]