Safety Study of OPC-12759 Ophthalmic Solution
2 other identifiers
interventional
100
1 country
1
Brief Summary
The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 3, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
June 29, 2021
CompletedJune 29, 2021
June 1, 2021
1 month
November 3, 2011
March 18, 2021
June 3, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Solution
EXPERIMENTALA single dose of OPC-12759 Ophthalmic solution for two-day treatment
Suspension
ACTIVE COMPARATORA single dose of OPC-12759 Ophthalmic suspension for two-day treatment
Interventions
Eligibility Criteria
You may qualify if:
- BMI : {body weight (kg) / \[height (m)\] 2 } must be 17.6 or greater, and less than 26.4 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kansai region
Osaka, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Otsuka Pharmaceutical Co., LTD.
Study Officials
- STUDY CHAIR
Eiji Murakami
Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2011
First Posted
November 11, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2011
Study Completion
February 1, 2012
Last Updated
June 29, 2021
Results First Posted
June 29, 2021
Record last verified: 2021-06