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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-04

Study Completion Date

2020-01-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

K-161 Ophthalmic Solution Dose A.

Group Type EXPERIMENTAL

K-161

Intervention Type DRUG

K-161 alternate dosage

Group 2

K-161 Ophthalmic Solution Dose B.

Group Type EXPERIMENTAL

K-161

Intervention Type DRUG

K-161 alternate dosage

Group 3

K-161 Ophthalmic Solution Dose C.

Group Type EXPERIMENTAL

K-161

Intervention Type DRUG

K-161 alternate dosage

Group 4

Vehicle Solution Dose.

Group Type PLACEBO_COMPARATOR

Placebo (Vehicle)

Intervention Type OTHER

Placebo solution

Interventions

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K-161

K-161 alternate dosage

Intervention Type DRUG

Placebo (Vehicle)

Placebo solution

Intervention Type OTHER

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No