What side effects are associated with this type of intervention?

Common treatments for Dry Eye Syndrome include cyclosporine ophthalmic solutions, diquafosol, and artificial tears. Cyclosporine can cause stinging, eyelid maceration, and in rare cases, increased intraocular pressure and cataracts. Diquafosol, a P2Y2 agonist, may cause mild irritation but is generally well-tolerated. Artificial tears, especially those with preservatives, can lead to irritation and allergic reactions. Preservative-free formulations are preferred to minimize these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Dry Eye Syndrome, including cyclosporine ophthalmic emulsion (Restasis), which helps increase tear production, and lifitegrast ophthalmic solution (Xiidra), which reduces inflammation associated with dry eye. Additionally, varenicline nasal spray (Tyrvaya) has been approved to stimulate tear production. These treatments aim to address the underlying causes of dry eye, such as inflammation and tear production deficiencies.

What other types of research exist?

Promising novel alternatives to K-161 Ophthalmic Solution for Dry Eye Syndrome patients include DE-089C, a long-acting diquafosol ophthalmic solution that improves corneal staining scores with less frequent dosing; OTX-101, a nanomicellar formulation of cyclosporine A that significantly increases tear production; and diquafosol tetrasodium, effective in both Sjögren's and non-Sjögren's dry eye patients unresponsive to artificial tears.

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K-161 Ophthalmic Solution for Dry Eye Disease

Phase 3

Waitlist Available

Research Sponsored by Kowa Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 85

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of K-161 are not listed, common side effects for ophthalmic solutions can include temporary discomfort, redness, blurred vision, watery eyes, or feeling like something is in your eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 85

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 85

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 85 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Schirmer's test

Change in ocular surface disease index (OSDI)

Change in tear film break-up time (TFBUT)

+1 more

Side effects data

From 2020 Phase 2 trial • 238 Patients • NCT04084483

10%

Instillation site pain

Dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Placebo (BID) (Vehicle)

0.025% K-161 (BID)

0.1% K-161 (BID)

0.1% K-161 (QID)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: K-161Experimental Treatment1 Intervention

K-161 Ophthalmic Solution

Group II: PlaceboPlacebo Group1 Intervention

Vehicle Solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

K-161

2019

Completed Phase 3

~890

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Dry Eye Syndrome (DES) work through various mechanisms to alleviate symptoms and improve ocular surface health. Artificial tears supplement the natural tear film, providing lubrication and reducing evaporation. Cationic emulsion-based eye drops mimic the natural tear film, restoring ocular surface homeostasis. Diquafosol ophthalmic solution, a P2Y2 receptor agonist, increases tear production and mucin secretion, enhancing tear film stability. Cyclosporine, an immunomodulator, reduces ocular surface inflammation, improving tear production and reducing symptoms. These treatments are crucial for DES patients as they address different aspects of tear film instability and ocular surface damage, providing symptomatic relief and preventing further ocular complications.

Cationic Emulsion-Based Artificial Tears as a Mimic of Functional Healthy Tear Film for Restoration of Ocular Surface Homeostasis in Dry Eye Disease.Netarsudil and latanoprost ophthalmic solution for the reduction of intraocular pressure in open-angle glaucoma or ocular hypertension.Clinical utility of 3% diquafosol ophthalmic solution in the treatment of dry eyes.