Safety Study of OPC-12759 Ophthalmic Solution

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Solution

A single dose of OPC-12759 Ophthalmic solution for two-day treatment

Group Type EXPERIMENTAL

OPC-12759 Ophthalmic solution

Intervention Type DRUG

2％ OPC-12759 Ophthalmic solution

Suspension

A single dose of OPC-12759 Ophthalmic suspension for two-day treatment

Group Type ACTIVE_COMPARATOR

OPC-12759 Ophthalmic suspension

Intervention Type DRUG

2％ OPC-12759 Ophthalmic suspension

Interventions

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OPC-12759 Ophthalmic solution

2％ OPC-12759 Ophthalmic solution

Intervention Type DRUG

OPC-12759 Ophthalmic suspension

2％ OPC-12759 Ophthalmic suspension

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI : {body weight (kg) / \[height (m)\] 2 } must be 17.6 or greater, and less than 26.4 kg/m2

Exclusion Criteria

1. Presence of ocular disorder
2. Intraocular pressure of 21mmHg or higher
3. Corrected visual acuity of less than 1.0
4. Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
5. History of refractive surgery
6. History of other ocular surgeries within 12 months
7. Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes