Status:
COMPLETED
Safety Study of OPC-12759 Ophthalmic Solution
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.
Eligibility Criteria
Inclusion
- BMI : {body weight (kg) / \[height (m)\] 2 } must be 17.6 or greater, and less than 26.4 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01471093
Start Date
November 1 2011
End Date
February 1 2012
Last Update
June 29 2021
Active Locations (1)
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1
Kansai region
Osaka, Japan