K-161 Ophthalmic Solution for Dry Eye Disease

Recruiting at 52 trial locations

Overseen By Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kowa Research Institute, Inc.

Disqualifiers: Ocular condition, Corneal surgery, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

644 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing K-161 eye drops to see if they are safe and effective for people with moderate to severe dry eye disease. The drops help keep the eyes moist and reduce irritation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug K-161 Ophthalmic Solution for treating dry eye disease?

The effectiveness of K-161 Ophthalmic Solution for dry eye disease might be supported by research on similar treatments like diquafosol tetrasodium, which has shown significant improvement in dry eye symptoms compared to artificial tears. Additionally, high molecular weight hyaluronan eye drops have been effective in improving symptoms of severe dry eye disease. ^{1 2 3 4 5}

How is the drug K-161 Ophthalmic Solution different from other treatments for dry eye disease?

The K-161 Ophthalmic Solution is unique because it is being specifically tested against a placebo in a clinical trial, which suggests it may have a novel mechanism or formulation compared to existing treatments like sodium hyaluronate or diquafosol tetrasodium, which are already established for dry eye disease. ^{1 6 7 8 9}

Research Team

Andrey E. Belous, MD, PhD

Principal Investigator

Kowa Pharma Development Co.

Eligibility Criteria

This trial is for adults with moderate to severe dry eye disease who have used eye drops for this condition. Participants must be at least 18 years old and meet all other protocol requirements. Those with significant eye conditions or recent ocular surgery are excluded.

Inclusion Criteria

Be at least 18 years of age at the time of Informed Consent

Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom

Meet all other inclusion criteria outlined in the clinical study protocol

Exclusion Criteria

Have any clinically significant ocular condition

Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months

Meet any other exclusion criteria outlined in the clinical study protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive K-161 ophthalmic solution or placebo for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue treatment in a 40-week extension study

40 weeks

Treatment Details

Interventions

• K-161 Ophthalmic Solution
• Placebo

Trial Overview The study is testing the effectiveness and safety of K-161 ophthalmic solution compared to a placebo in treating dry eye disease. Participants will receive either the actual medication or a placebo without knowing which one they're getting.

Participant Groups

Group I: K-161 Experimental Treatment 1 Intervention

K-161 Ophthalmic Solution

Group II: Placebo Placebo Group 1 Intervention

Vehicle Solution

Who Is Running the Clinical Trial?

Kowa Research Institute, Inc.

Lead Sponsor

Trials

46

Recruited

16,400+

Findings from Research

In a study involving 84 patients with severe dry eye disease, substituting their regular artificial tears with 0.15% high molecular weight hyaluronan (HMWHA) eye drops led to a significant improvement in symptoms, as measured by the Ocular Surface Disease Index (OSDI), with an average improvement of 13.5 points after 8 weeks.

The use of HMWHA eye drops also resulted in a slight improvement in best corrected visual acuity (BCVA), indicating that these drops can enhance patient comfort and vision without negatively affecting other dry eye signs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HYLAN M Study: Efficacy of 0.15% High Molecular Weight Hyaluronan Fluid in the Treatment of Severe Dry Eye Disease in a Multicenter Randomized Trial. van Setten, GB., Baudouin, C., Horwath-Winter, J., et al.[2020]

In a randomized, double-blind crossover trial involving 70 subjects, a 0.1% hyaluronan solution significantly improved objective measures of dry eye syndrome, such as Schirmer's score and rose bengal staining score, compared to 0.9% saline.

Subjects reported that hyaluronan was more effective than saline in relieving symptoms like burning and grittiness, and no adverse events were linked to hyaluronan treatment, indicating it is safe and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome. Condon, PI., McEwen, CG., Wright, M., et al.[2019]

References

1. India pubmed.ncbi.nlm.nih.gov

Safety and efficacy of topical diquafosol for the treatment of dry eye disease: An updated meta-analysis of randomized controlled trials. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Cyclosporine 0.05% ophthalmic emulsion for dry eye in Korea: a prospective, multicenter, open-label, surveillance study. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The HYLAN M Study: Efficacy of 0.15% High Molecular Weight Hyaluronan Fluid in the Treatment of Severe Dry Eye Disease in a Multicenter Randomized Trial. [2020]

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

Efficacy of lodoxamide 0.1% ophthalmic solution in resolving corneal epitheliopathy associated with vernal keratoconjunctivitis. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Clinical study of the effectiveness of a dexpanthenol containing artificial tears solution (Siccaprotect) in treatment of dry eyes]. [2014]

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

Treatment of patients with keratoconjunctivitis sicca with Optive: results of a multicenter, open-label observational study in Germany. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome. [2019]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Artificial tear drops Thealoz in the correction of dry eye syndrome after keratorefractive surgery]. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of hypotonic and isotonic solutions containing sodium hyaluronate on the symptomatic treatment of dry eye patients. [2017]