Safety Study of OPC-12759 Ophthalmic Solution

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Rebamipide

Criteria

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