A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease

Kowa

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Placebo; Drug: K-161

Study type: Interventional

Funder types: Industry

Identifiers

NCT05403827

K-161-3.01

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of K-161 ophthalmic solution for the treatment of moderate to severe dry eye disease.

Enrollment: 644 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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644 participants in 2 patient groups, including a placebo group

K-161

Experimental group

Description:

K-161 Ophthalmic Solution

Treatment:

Drug: K-161

Placebo

Placebo Comparator group

Description:

Vehicle Solution

Treatment:

Drug: Placebo