Safety Study of OPC-12759 Ophthalmic Solution

Phase 1

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: OPC-12759 Ophthalmic solution; Drug: OPC-12759 Ophthalmic suspension

• Registration Number: NCT01471093
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Results First Submitted: 2021-03-18
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-03
• Last Update Submitted: 2021-06-03
• Results First Posted: 2021-06-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Solution	OPC-12759 Ophthalmic solution	A single dose of OPC-12759 Ophthalmic solution for two-day treatment
Suspension	OPC-12759 Ophthalmic suspension	A single dose of OPC-12759 Ophthalmic suspension for two-day treatment

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Blurred Vision After Instillation	The first and second instillation	The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.
Number of Subjects With Bitter Taste	The first and second instillation	The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.

Trial Locations

Locations (1)

Kansai region; 🇯🇵 Osaka, Japan