Dry Eye Syndromes
Conditions
Brief summary
The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.
Interventions
DRUGOPC-12759 Ophthalmic solution
2％ OPC-12759 Ophthalmic solution
2％ OPC-12759 Ophthalmic suspension
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Participant flow
Recruitment details
This study was a single-center, randomized, crossover, open-label study.
Participants by arm
| Arm | Count |
|---|---|
| OPC-12759 Solution One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. | 50 |
| OPC-12759 Suspension One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | OPC-12759 Solution | OPC-12759 Suspension |
|---|---|---|---|
| Age, Continuous | 26.9 years STANDARD_DEVIATION 6.3 | 27.8 years STANDARD_DEVIATION 6.3 | 25.9 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment Japan | 100 Participants | 50 Participants | 50 Participants |
| Sex: Female, Male Female | 55 Participants | 28 Participants | 27 Participants |
| Sex: Female, Male Male | 45 Participants | 22 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 6 / 50 | 2 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Number of Subjects With Bitter Taste
The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.
Time frame: The first and second instillation
Population: Analysis set consisted of all subjects who had received the investigational product at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPC-12759 Solution With Nasal Root Pressed/Not Pressed | Number of Subjects With Bitter Taste | With Nasal Root Press | 33 participants |
| OPC-12759 Solution With Nasal Root Pressed/Not Pressed | Number of Subjects With Bitter Taste | Without Nasal Root Press | 41 participants |
| OPC-12759 Suspension With Nasal Root Pressed/Not Pressed | Number of Subjects With Bitter Taste | With Nasal Root Press | 23 participants |
| OPC-12759 Suspension With Nasal Root Pressed/Not Pressed | Number of Subjects With Bitter Taste | Without Nasal Root Press | 29 participants |
Primary
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.
Time frame: The first and second instillation
Population: Analysis set consisted of all subjects who had received the investigational product at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OPC-12759 Solution With Nasal Root Pressed/Not Pressed | Number of Subjects With Blurred Vision After Instillation | With Nasal Root Press | 0 participants |
| OPC-12759 Solution With Nasal Root Pressed/Not Pressed | Number of Subjects With Blurred Vision After Instillation | Without Nasal Root Press | 0 participants |
| OPC-12759 Suspension With Nasal Root Pressed/Not Pressed | Number of Subjects With Blurred Vision After Instillation | With Nasal Root Press | 10 participants |
| OPC-12759 Suspension With Nasal Root Pressed/Not Pressed | Number of Subjects With Blurred Vision After Instillation | Without Nasal Root Press | 21 participants |