Trial Outcomes & Findings for Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis (NCT NCT01848041)
NCT ID: NCT01848041
Last Updated: 2021-11-26
Results Overview
The mean change from baseline (Day 0, Hour 0) in number of points seen on the HVF 36-point ptosis protocol test according to a pre-planned hierarchical analysis as follows: 1. Hour 6 on Visit 4 (Day 13) for the BID regimen versus vehicle 2. Hour 6 on Visit 4 (Day 13) for the QD regimen versus vehicle 3. Hour 2 on Visit 4 (Day 13) for the BID regimen versus vehicle 4. Hour 2 on Visit 4 (Day 13) for the QD regimen versus vehicle Testing was performed using a Humphrey perimeter at a grid of 36 points confined to the superior hemifield extending 55° to either side of fixation and 45° superior to fixation. Testing was accomplished in the standard fashion using a varying 4-mm2 or 5-mm2 stimulus to determine the visual sensitivity for each grid point in the field (Riemann et al, 2000). A 4-mm2 stimulus was acceptable, but a 5-mm2 stimulus was preferred, if available.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)
Results posted on
2021-11-26
Participant Flow
Participant milestones
| Measure |
RVL-1201 QD
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 BID
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Vehicle (Placebo) BID
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
15
|
|
Overall Study
COMPLETED
|
15
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis
Baseline characteristics by cohort
| Measure |
RVL-1201 QD
n=15 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 BID
n=16 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Vehicle (Placebo) BID
n=15 Participants
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo
|
Total
n=46 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
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 10.47 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 11.23 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 10.80 • n=4 Participants
|
|
Age, Customized
|
63 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
61.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
41 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
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OD · Blue
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OD · Brown
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OD · Green
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OD · Hazel
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OD · Grey
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OD · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OS · Blue
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OS · Brown
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OS · Green
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OS · Hazel
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OS · Grey
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Iris Color OD/OS
Iris Color OS · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Lens Status OD/OS
Lens Status OD · Phakic, a person with an intact natural lens
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Lens Status OD/OS
Lens Status OD · Aphakic, a person with a natural lens was extracted and no intraocular lens was implanted.
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Lens Status OD/OS
Lens Status OD · Pseudophakic, a person who has had a lens extracted and an intraocular lens placed
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Lens Status OD/OS
Lens Status OS · Phakic, a person with an intact natural lens
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Lens Status OD/OS
Lens Status OS · Aphakic, a person with a natural lens was extracted and no intraocular lens was implanted.
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Lens Status OD/OS
Lens Status OS · Pseudophakic, a person who has had a lens extracted and an intraocular lens placed
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)Population: Intent to Treat Population
The mean change from baseline (Day 0, Hour 0) in number of points seen on the HVF 36-point ptosis protocol test according to a pre-planned hierarchical analysis as follows: 1. Hour 6 on Visit 4 (Day 13) for the BID regimen versus vehicle 2. Hour 6 on Visit 4 (Day 13) for the QD regimen versus vehicle 3. Hour 2 on Visit 4 (Day 13) for the BID regimen versus vehicle 4. Hour 2 on Visit 4 (Day 13) for the QD regimen versus vehicle Testing was performed using a Humphrey perimeter at a grid of 36 points confined to the superior hemifield extending 55° to either side of fixation and 45° superior to fixation. Testing was accomplished in the standard fashion using a varying 4-mm2 or 5-mm2 stimulus to determine the visual sensitivity for each grid point in the field (Riemann et al, 2000). A 4-mm2 stimulus was acceptable, but a 5-mm2 stimulus was preferred, if available.
Outcome measures
| Measure |
RVL-1201 Once Daily
n=15 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Twice Daily
n=16 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Vehicle (Placebo)
n=15 Participants
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo
|
|---|---|---|---|
|
Humphrey Visual Field
Visit 4 (Day 13, Hour 6)
|
15.9 Points seen
Standard Deviation 5.29
|
17.0 Points seen
Standard Deviation 4.51
|
17.1 Points seen
Standard Deviation 5.02
|
|
Humphrey Visual Field
Base Line (Day 0, Hour 0)
|
9.8 Points seen
Standard Deviation 5.07
|
12.1 Points seen
Standard Deviation 4.64
|
11.1 Points seen
Standard Deviation 4.74
|
|
Humphrey Visual Field
Visit 4 (Day 13, Hour 2)
|
16.1 Points seen
Standard Deviation 5.35
|
15.7 Points seen
Standard Deviation 4.63
|
15.7 Points seen
Standard Deviation 5.64
|
SECONDARY outcome
Timeframe: Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)Population: Intent to Treat Population
Change from baseline in MRD by regimen against placebo and between regimen. The distance from the pupillary light reflex to the central margin of the upper eyelid is the MRD. The MRD will be measured from the external photograph using calipers and the millimeter ruler as the legend.
Outcome measures
| Measure |
RVL-1201 Once Daily
n=15 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Twice Daily
n=16 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Vehicle (Placebo)
n=15 Participants
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo
|
|---|---|---|---|
|
Marginal Reflex Distance
Baseline (Day 0, Hour 0)
|
1.6 Millimeters (mm)
Standard Deviation 0.77
|
1.6 Millimeters (mm)
Standard Deviation 0.84
|
1.6 Millimeters (mm)
Standard Deviation 0.63
|
|
Marginal Reflex Distance
Visit 4 (Day 13, Hour 2)
|
2.4 Millimeters (mm)
Standard Deviation 0.99
|
2.3 Millimeters (mm)
Standard Deviation 1.19
|
2.0 Millimeters (mm)
Standard Deviation 0.95
|
|
Marginal Reflex Distance
Visit 4 (Day 13, Hour 6)
|
2.4 Millimeters (mm)
Standard Deviation 1.00
|
2.5 Millimeters (mm)
Standard Deviation 1.13
|
2.2 Millimeters (mm)
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)Population: Intent to Treat Population
Change from baseline in PFD by regimen against placebo and between regimen. The PFD is the distance from the upper lid margin to the lower lid margin measured through the central visual axis. It will be measured from the external photograph using handheld calipers and the millimeter ruler as the legend.
Outcome measures
| Measure |
RVL-1201 Once Daily
n=15 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Twice Daily
n=16 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Vehicle (Placebo)
n=15 Participants
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo
|
|---|---|---|---|
|
Palpebral Fissure Distance Measurement
Baseline (Day 0, Hour 0)
|
6.2 Millimeters (mm)
Standard Deviation 1.16
|
6.5 Millimeters (mm)
Standard Deviation 1.10
|
6.5 Millimeters (mm)
Standard Deviation 1.55
|
|
Palpebral Fissure Distance Measurement
Visit 4 (Day 13, Hour 2)
|
6.9 Millimeters (mm)
Standard Deviation 1.35
|
7.1 Millimeters (mm)
Standard Deviation 1.72
|
6.6 Millimeters (mm)
Standard Deviation 1.67
|
|
Palpebral Fissure Distance Measurement
Visit 4 (Day 13, Hour 6)
|
7.0 Millimeters (mm)
Standard Deviation 1.51
|
7.5 Millimeters (mm)
Standard Deviation 1.45
|
6.8 Millimeters (mm)
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)Population: Intent to Treat Population
Change from baseline in CS by regimen against placebo and between regimen. The Pelli-Robson contrast sensitivity chart will be used at a distance of 1 meter. The subject was instructed to begin reading the letters at the top of the chart and to continue reading across and down the chart. Testing was discontinued when 2 of 3 letters were named incorrectly. The test was scored using the letter-by-letter method where a value of 0.05 log CS is given per correct letter (Haymes et al, 2006).
Outcome measures
| Measure |
RVL-1201 Once Daily
n=15 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Twice Daily
n=16 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Vehicle (Placebo)
n=15 Participants
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo
|
|---|---|---|---|
|
Contrast Sensitivity
Baseline (Day 0, Hour 0)
|
33.1 Letters Read
Standard Deviation 4.05
|
34.7 Letters Read
Standard Deviation 6.14
|
33.3 Letters Read
Standard Deviation 5.81
|
|
Contrast Sensitivity
Visit 4 (Day 13, Hour 2)
|
34.7 Letters Read
Standard Deviation 4.45
|
35.8 Letters Read
Standard Deviation 4.28
|
35.3 Letters Read
Standard Deviation 4.79
|
|
Contrast Sensitivity
Visit 4 (Day 13, Hour 6)
|
35.5 Letters Read
Standard Deviation 3.81
|
36.8 Letters Read
Standard Deviation 3.29
|
35.1 Letters Read
Standard Deviation 4.18
|
SECONDARY outcome
Timeframe: Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)Population: Intent to Treat Population
Change from baseline in VA by regimen against placebo and between regimen. Corrected Snellen VA measurement was performed with the Snellen eye chart using subjects current corrective lens prescription at a distance equivalent to 20 feet (6 meters).
Outcome measures
| Measure |
RVL-1201 Once Daily
n=15 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Twice Daily
n=16 Participants
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Vehicle (Placebo)
n=15 Participants
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo
|
|---|---|---|---|
|
Corrected Snellen Visual Acuity
Baseline (Day 0, Hour 0)
|
0.071 LogMAR
Standard Deviation 0.0859
|
0.086 LogMAR
Standard Deviation 0.0988
|
0.081 LogMAR
Standard Deviation 0.0770
|
|
Corrected Snellen Visual Acuity
Visit 4 (Day 13, Hour 2)
|
0.055 LogMAR
Standard Deviation 0.0739
|
0.024 LogMAR
Standard Deviation 0.1043
|
0.059 LogMAR
Standard Deviation 0.1190
|
|
Corrected Snellen Visual Acuity
Visit 4 (Day 13, Hour 6)
|
0.026 LogMAR
Standard Deviation 0.0891
|
0.023 LogMAR
Standard Deviation 0.0949
|
0.053 LogMAR
Standard Deviation 0.1018
|
Adverse Events
RVL-1201 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
RVL-1201 BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
RVL-1201 Vehicle (Placebo) BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RVL-1201 QD
n=15 participants at risk
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 BID
n=16 participants at risk
RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201: RVL-1201 0.1% Ophthalmic Solution
|
RVL-1201 Vehicle (Placebo) BID
n=15 participants at risk
RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose
RVL-1201 Vehicle Placebo: RVL-1201 Vehicle Placebo
|
|---|---|---|---|
|
Eye disorders
Punctate keratitis
|
6.7%
1/15 • Number of events 2 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/16 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
6.2%
1/16 • Number of events 2 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
|
General disorders
Instillation Site Dryness
|
6.7%
1/15 • Number of events 2 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/16 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
|
General disorders
Instillation Site Foreign Body Sensation
|
6.7%
1/15 • Number of events 2 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
12.5%
2/16 • Number of events 4 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
|
General disorders
Instillation Site Pruritus
|
6.7%
1/15 • Number of events 4 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
6.2%
1/16 • Number of events 2 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
|
General disorders
Instillation Site Pain
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
12.5%
2/16 • Number of events 3 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/16 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
0.00%
0/16 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
6.7%
1/15 • Number of events 1 • 14 Days
AEs were those with onset after randomization or if occurring prior to randomization, that worsened after randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place