K-161 Ophthalmic Solution for Dry Eye Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new eye drop, K-161 Ophthalmic Solution, to evaluate its effectiveness and safety for treating moderate to severe dry eye disease. Participants will receive either the K-161 eye drops or a placebo (a solution without active medication) to compare effects. Individuals with dry eye in both eyes who regularly use eye drops may be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to the development of a potentially groundbreaking treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that K-161 eye drops have been tested for safety in people with moderate to severe dry eye disease. Studies found that some patients experienced mild and short-term side effects, such as eye irritation, eye inflammation, dry eye, small spots on the cornea, and blurred vision. These side effects were uncommon, affecting about 9.6% of participants. Overall, the findings suggest that K-161 is generally well-tolerated, with most side effects being minor and temporary.12345
Why do researchers think this study treatment might be promising for dry eye disease?
Unlike other treatments for dry eye disease, which often focus on providing moisture through artificial tears or reducing inflammation with medications like cyclosporine, K-161 Ophthalmic Solution is unique because it offers a new approach. Researchers are excited about K-161 because it targets specific pathways involved in tear production and eye surface health, potentially leading to more effective and long-lasting relief. This novel mechanism of action could significantly improve the quality of life for those suffering from dry eye disease, providing an alternative to current therapies that may not fully address the underlying causes.
What evidence suggests that K-161 Ophthalmic Solution might be an effective treatment for dry eye disease?
Research has shown that K-161 eye drops, which participants in this trial may receive, could help treat dry eye disease. In a study with 70 people, a similar solution containing 0.1% hyaluronan significantly improved dry eye symptoms and helped stabilize the tear layer on the eye. Another study found that individuals using K-161 experienced fewer symptoms, as measured by the Ocular Surface Disease Index (OSDI), which assesses the severity of dry eye symptoms. These findings suggest that K-161 could be effective for those with moderate to severe dry eye disease.12456
Who Is on the Research Team?
Andrey E. Belous, MD, PhD
Principal Investigator
Kowa Pharma Development Co.
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive K-161 ophthalmic solution or placebo for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue treatment in a 40-week extension study
What Are the Treatments Tested in This Trial?
Interventions
- K-161 Ophthalmic Solution
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kowa Research Institute, Inc.
Lead Sponsor