Safety Study of OPC-12759 Ophthalmic Solution

Otsuka

Status and phase: Completed; Phase 1

Conditions: Dry Eye Syndromes

Treatments: Drug: OPC-12759 Ophthalmic solution; Drug: OPC-12759 Ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01471093

037E-11-004

JapicCTI-111674 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Solution

Experimental group

Description:

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

Treatment:

Drug: OPC-12759 Ophthalmic solution

Suspension

Active Comparator group

Description:

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

Treatment:

Drug: OPC-12759 Ophthalmic suspension