Trial Outcomes & Findings for Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia (NCT NCT05665387)
NCT ID: NCT05665387
Last Updated: 2024-05-29
Results Overview
Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
At Month 2
Results posted on
2024-05-29
Participant Flow
Participant milestones
| Measure |
0.3% STN1013600 Ophthalmic Solution
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
16
|
|
Overall Study
COMPLETED
|
29
|
33
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
0.3% STN1013600 Ophthalmic Solution
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
Baseline Characteristics
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia
Baseline characteristics by cohort
| Measure |
0.3% STN1013600 Ophthalmic Solution
n=30 Participants
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
n=33 Participants
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
n=16 Participants
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 2.20 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 2.51 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 1.78 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 2.25 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
33 participants
n=7 Participants
|
16 participants
n=5 Participants
|
79 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 2Population: Full Analysis Set (FAS) included all randomized subjects. The number analyzed are participants evaluable for the outcome measure at Month 2.
Analysis of Change from Baseline at Month 2 was done using Bayesian Approach Analysis Population.
Outcome measures
| Measure |
0.3% STN1013600 Ophthalmic Solution
n=30 Participants
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
n=33 Participants
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
n=15 Participants
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
|---|---|---|---|
|
Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA)
|
4.1 EDTRS letters
Standard Error 1.24
|
4.3 EDTRS letters
Standard Error 1.18
|
4.4 EDTRS letters
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Month 2Population: Full Analysis Set (observed cases only).
Summary of Early Treatment Diabetic Retinopathy Study (ETDRS) Letters and Change from Baseline by Analysis Visit.
Outcome measures
| Measure |
0.3% STN1013600 Ophthalmic Solution
n=30 Participants
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
n=33 Participants
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
n=15 Participants
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
|---|---|---|---|
|
Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Baseline Observed
|
62.2 EDTRS letters
Standard Deviation 6.29
|
63.5 EDTRS letters
Standard Deviation 4.84
|
63.8 EDTRS letters
Standard Deviation 4.71
|
|
Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Month 2 Observed
|
66.4 EDTRS letters
Standard Deviation 6.69
|
67.9 EDTRS letters
Standard Deviation 8.10
|
68.7 EDTRS letters
Standard Deviation 7.58
|
|
Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Month 2 Change from Baseline
|
4.2 EDTRS letters
Standard Deviation 6.65
|
4.4 EDTRS letters
Standard Deviation 7.15
|
4.8 EDTRS letters
Standard Deviation 5.88
|
SECONDARY outcome
Timeframe: Month 2Population: Full Analysis Set (observed cases only).
The response rate is the percentage of participants that achieved the specified gain in Distance Corrected Intermediate Visual Acuity (DCIVA) without losing more than 5 ETDRS (Early Treatment Diabetic Retinopathy Study) letters in Best Corrected Distance Visual Acuity (BCDVA)
Outcome measures
| Measure |
0.3% STN1013600 Ophthalmic Solution
n=30 Participants
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
n=33 Participants
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
n=15 Participants
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
|---|---|---|---|
|
Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Month 2 Having a gain of 5 or more letters in DCIVA without loosing more than 5 letters in BCDVA
|
13 Participants
|
17 Participants
|
5 Participants
|
|
Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Month 2 Having a gain of 10 or more letters in DCIVA without loosing more than 5 letters in BCDVA
|
6 Participants
|
12 Participants
|
0 Participants
|
|
Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2
Month 2 Having a gain of 15 or more letters in DCIVA without loosing more than 5 letters in BCDVA
|
1 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 2Population: Full Analysis Set (observed cases only).
Analysis of change from baseline in Rasch Score was done using Mixed-Effects Model for Repeated Measures (MMRM). Least Square Means were obtained by fitting a MMRM model to the NAVQ values. The summated NAVQ score from initial 10 questions ranged from 0 to 30, where higher score indicates more difficulty with near tasks. The summated NAVQ score is converted to Rasch score which ranged from 0 to 100, with higher values indicating more difficulty with near tasks.
Outcome measures
| Measure |
0.3% STN1013600 Ophthalmic Solution
n=30 Participants
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
n=33 Participants
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
n=15 Participants
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
|---|---|---|---|
|
Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2
|
-7.493 score on a scale
Standard Error 2.1803
|
-8.140 score on a scale
Standard Error 2.0939
|
-10.510 score on a scale
Standard Error 3.1447
|
SECONDARY outcome
Timeframe: Month 2Population: Full Analysis Set (Observed cases only)
The response rate is the percent of participants that responded with "Satisfactory" or "Very Satisfactory" when asked to rate the overall satisfaction with the treatment.
Outcome measures
| Measure |
0.3% STN1013600 Ophthalmic Solution
n=30 Participants
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
n=33 Participants
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
n=15 Participants
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
|---|---|---|---|
|
Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment
|
13 Participants
|
18 Participants
|
9 Participants
|
Adverse Events
0.3% STN1013600 Ophthalmic Solution
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
0.1% STN1013600 Ophthalmic Solution
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo (Vehicle) Ophthalmic Solution
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 |
0.3% STN1013600 Ophthalmic Solution
n=30 participants at risk
0.3% STN1013600 ophthalmic solution 1 drop BID
0.3% STN1013600 ophthalmic solution: 0.3% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
0.1% STN1013600 Ophthalmic Solution
n=33 participants at risk
0.1% STN1013600 ophthalmic solution 1 drop BID
0.1% STN1013600 ophthalmic solution: 0.1% STN1013600 ophthalmic solution 1 drop BID for 2 months
|
Placebo (Vehicle) Ophthalmic Solution
n=16 participants at risk
Placebo (Vehicle) ophthalmic solution BID
Placebo: Placebo ophthalmic solution 1 drop BID for 2 months
|
|---|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
3.0%
1/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
3.0%
1/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
3.0%
1/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Eye disorders
Visual acuity reduced
|
3.3%
1/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
General disorders
Instillation site irritation
|
3.3%
1/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
6.1%
2/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
General disorders
Instillation site discomfort
|
3.3%
1/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Investigations
Liver function test increased
|
3.3%
1/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
6.1%
2/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Investigations
White blood cell count increased
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
3.0%
1/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
3.0%
1/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
3.3%
1/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
3.0%
1/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
3.0%
1/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.3%
1/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
6.2%
1/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
|
Psychiatric disorders
Depression
|
0.00%
0/30 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
0.00%
0/33 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
6.2%
1/16 • Adverse events in this study were collected from the time of informed consent and until subject withdrawal or until the subject's participation in the study ended at 3 Months.
Reported AEs were followed by the investigator until resolution, stabilization, the event was otherwise explained, or the participant is lost to follow up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place