A Study Assessing the Safety, Efficacy, and Optimum Dosage of K-161 in Subjects With Moderate to Severe Dry Eye Disease

Kowa

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Other: Placebo (Vehicle); Drug: K-161

Study type: Interventional

Funder types: Industry

Identifiers

NCT04084483

K-161-2.01US

Details and patient eligibility

About

The objective of the study is to assess the safety, efficacy, optimum dosage, and dosing regimen of K-161 in adult subjects with moderate to severe dry eye disease.

Enrollment: 238 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 visit.
• Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptoms.
• Meet all 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.
• Must not 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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238 participants in 4 patient groups, including a placebo group

Group 1

Experimental group

Description:

K-161 Ophthalmic Solution Dose A.

Treatment:

Drug: K-161

Group 2

Experimental group

Description:

K-161 Ophthalmic Solution Dose B.

Treatment:

Drug: K-161

Group 3

Experimental group

Description:

K-161 Ophthalmic Solution Dose C.

Treatment:

Drug: K-161

Group 4

Placebo Comparator group

Description:

Vehicle Solution Dose.

Treatment:

Other: Placebo (Vehicle)