Trial Outcomes & Findings for Safety Study of OPC-12759 Ophthalmic Solution (NCT NCT01471093)
NCT ID: NCT01471093
Last Updated: 2021-06-29
Results Overview
The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
100 participants
Primary outcome timeframe
The first and second instillation
Results posted on
2021-06-29
Participant Flow
This study was a single-center, randomized, crossover, open-label study.
Participant milestones
| Measure |
OPC-12759 Solution With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed
One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
OPC-12759 Solution Without Nasal Root Pressed, Then OPC-12759 With Nasal Root Pressed
One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
OPC-12759 Suspension With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed
One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
OPC-12759 Suspension Without Nasal Root Pressed, Then OPC-12759 Solution With Nasal Root Pressed
One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
OPC-12759 Solution With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed
One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
OPC-12759 Solution Without Nasal Root Pressed, Then OPC-12759 With Nasal Root Pressed
One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
OPC-12759 Suspension With Nasal Root Pressed, Then OPC-12759 Solution Without Nasal Root Pressed
One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
OPC-12759 Suspension Without Nasal Root Pressed, Then OPC-12759 Solution With Nasal Root Pressed
One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety Study of OPC-12759 Ophthalmic Solution
Baseline characteristics by cohort
| Measure |
OPC-12759 Solution
n=50 Participants
One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once.
|
OPC-12759 Suspension
n=50 Participants
One drop of OPC-12759 ophthalmic suspension was instilled into each eye once.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
25.9 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
26.9 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The first and second instillationPopulation: Analysis set consisted of all subjects who had received the investigational product at least once.
The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.
Outcome measures
| Measure |
OPC-12759 Solution With Nasal Root Pressed/Not Pressed
n=50 Participants
One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
OPC-12759 Suspension With Nasal Root Pressed/Not Pressed
n=50 Participants
One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
|---|---|---|
|
Number of Subjects With Blurred Vision After Instillation
Without Nasal Root Press
|
0 participants
|
21 participants
|
|
Number of Subjects With Blurred Vision After Instillation
With Nasal Root Press
|
0 participants
|
10 participants
|
PRIMARY outcome
Timeframe: The first and second instillationPopulation: Analysis set consisted of all subjects who had received the investigational product at least once.
The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.
Outcome measures
| Measure |
OPC-12759 Solution With Nasal Root Pressed/Not Pressed
n=50 Participants
One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
OPC-12759 Suspension With Nasal Root Pressed/Not Pressed
n=50 Participants
One drop of OPC-12759 ophthalmic suspension was instilled into each eye once. Subjects who were instructed to press the nasal root at the first instillation (n=25) were asked not to press it at the second instillation, and subjects who were instructed not to press the nasal root at the first instillation (n=25) were asked to press it at the second instillation.
The second instillation was conducted within 14 days after the first instillation.
|
|---|---|---|
|
Number of Subjects With Bitter Taste
With Nasal Root Press
|
33 participants
|
23 participants
|
|
Number of Subjects With Bitter Taste
Without Nasal Root Press
|
41 participants
|
29 participants
|
Adverse Events
OPC-12759 Solution
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OPC-12759 Suspension
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OPC-12759 Solution
n=50 participants at risk
One drop of 2% OPC-12759 ophthalmic solution was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation).
|
OPC-12759 Suspension
n=50 participants at risk
One drop of OPC-12759 ophthalmic suspension was instilled into each eye (instillation was conducted twice, the second instillation was within 14 days after the first instillation).
|
|---|---|---|
|
Eye disorders
Chalazion
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Infections and infestations
Herpes zoster
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Investigations
Protein urine present
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Nervous system disorders
Headache
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.0%
1/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
0.00%
0/50 • Treatment period (2 days up to 15 days)
Safety analysis set consisted of all subjects who had received the investigational product at least once. White blurred vision after instillation and bitter taste were not considered to be adverse events because they were the specific symptoms for study evaluation. Adverse Events detected were systemic and not attributable to one specific intervention or another.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place