Safety Study of OPC-12759 Ophthalmic Solution

Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: OPC-12759 Ophthalmic solution; Drug: OPC-12759 Ophthalmic suspension

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Kansai Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solution; A single dose of OPC-12759 Ophthalmic solution for two-day treatment	Drug: OPC-12759 Ophthalmic solution; 2％ OPC-12759 Ophthalmic solution
Active Comparator: Suspension; A single dose of OPC-12759 Ophthalmic suspension for two-day treatment	Drug: OPC-12759 Ophthalmic suspension; 2％ OPC-12759 Ophthalmic suspension

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Eiji Murakami, Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: November 3, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (Estimate): November 11, 2011

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Pharmaceutical Solutions; Ophthalmic Solutions; Rebamipide
• Other Study ID Numbers: 037E-11-004; JapicCTI-111674 (Other Identifier: Japic)