Back to resultsSafety Study of OPC-12759 Ophthalmic Solution
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
OPC-12759 Ophthalmic solution
OPC-12759 Ophthalmic suspension
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility 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:
- Presence of ocular disorder
- Intraocular pressure of 21mmHg or higher
- Corrected visual acuity of less than 1.0
- Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
- History of refractive surgery
- History of other ocular surgeries within 12 months
- Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose
Sites / Locations
- Kansai region
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Solution
Suspension
Arm Description
A single dose of OPC-12759 Ophthalmic solution for two-day treatment
A single dose of OPC-12759 Ophthalmic suspension for two-day treatment
Outcomes
Primary Outcome Measures
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.
Number of Subjects With Bitter Taste
The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.
Secondary Outcome Measures
Full Information
NCT ID
NCT01471093
First Posted
November 3, 2011
Last Updated
June 3, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01471093
Brief Title
Safety Study of OPC-12759 Ophthalmic Solution
Official Title
Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solution
Arm Type
Experimental
Arm Description
A single dose of OPC-12759 Ophthalmic solution for two-day treatment
Arm Title
Suspension
Arm Type
Active Comparator
Arm Description
A single dose of OPC-12759 Ophthalmic suspension for two-day treatment
Intervention Type
Drug
Intervention Name(s)
OPC-12759 Ophthalmic solution
Intervention Description
2％ OPC-12759 Ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
OPC-12759 Ophthalmic suspension
Intervention Description
2％ OPC-12759 Ophthalmic suspension
Primary Outcome Measure Information:
Title
Number of Subjects With Blurred Vision After Instillation
Description
The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.
Time Frame
The first and second instillation
Title
Number of Subjects With Bitter Taste
Description
The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.
Time Frame
The first and second instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
Presence of ocular disorder
Intraocular pressure of 21mmHg or higher
Corrected visual acuity of less than 1.0
Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
History of refractive surgery
History of other ocular surgeries within 12 months
Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eiji Murakami
Organizational Affiliation
Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Kansai region
City
Osaka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Safety Study of OPC-12759 Ophthalmic Solution
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