Trial Outcomes & Findings for LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration (NCT NCT02355028)
NCT ID: NCT02355028
Last Updated: 2018-07-02
Results Overview
For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
Day 84
Results posted on
2018-07-02
Participant Flow
Subjects were recruited from 20 study centers located in the United States.
Of the 136 enrolled, 37 subjects were exited as screen failures and another 6 subjects were discontinued prior to randomization. This reporting group includes all randomized subjects (93).
Participant milestones
| Measure |
LHA510
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
|
Overall Study
Treated
|
46
|
45
|
|
Overall Study
COMPLETED
|
36
|
41
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
| Measure |
LHA510
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Deemed ineligible after randomization
|
8
|
4
|
Baseline Characteristics
All subjects who met amendment 4 entry criteria, received any dose of IP, had at least 1 follow-up visit with an assessment for primary endpoint, and had no critical protocol deviations, or discontinued the study due to lack of efficacy or tolerability before Day 84 (Extended PPS-A4).
Baseline characteristics by cohort
| Measure |
LHA510
n=46 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=45 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.3 years
STANDARD_DEVIATION 7.74 • n=46 Participants
|
76.8 years
STANDARD_DEVIATION 7.94 • n=45 Participants
|
77.1 years
STANDARD_DEVIATION 7.80 • n=91 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=46 Participants
|
28 Participants
n=45 Participants
|
50 Participants
n=91 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=46 Participants
|
17 Participants
n=45 Participants
|
41 Participants
n=91 Participants
|
|
Central Subfield Thickness Total (CSFTtot)
|
350.5 μm
STANDARD_DEVIATION 107.09 • n=33 Participants • All subjects who met amendment 4 entry criteria, received any dose of IP, had at least 1 follow-up visit with an assessment for primary endpoint, and had no critical protocol deviations, or discontinued the study due to lack of efficacy or tolerability before Day 84 (Extended PPS-A4).
|
374.9 μm
STANDARD_DEVIATION 116.98 • n=37 Participants • All subjects who met amendment 4 entry criteria, received any dose of IP, had at least 1 follow-up visit with an assessment for primary endpoint, and had no critical protocol deviations, or discontinued the study due to lack of efficacy or tolerability before Day 84 (Extended PPS-A4).
|
363.4 μm
STANDARD_DEVIATION 112.29 • n=70 Participants • All subjects who met amendment 4 entry criteria, received any dose of IP, had at least 1 follow-up visit with an assessment for primary endpoint, and had no critical protocol deviations, or discontinued the study due to lack of efficacy or tolerability before Day 84 (Extended PPS-A4).
|
|
Best-corrected visual acuity (BCVA)
|
71.2 letters
STANDARD_DEVIATION 9.45 • n=33 Participants • Extended PPS-A4
|
70.5 letters
STANDARD_DEVIATION 8.87 • n=37 Participants • Extended PPS-A4
|
70.9 letters
STANDARD_DEVIATION 9.09 • n=70 Participants • Extended PPS-A4
|
|
Central Subfield Thickness Neuro-Retina (CSFTnr)
|
242.2 μm
STANDARD_DEVIATION 48.95 • n=33 Participants • Extended PPS-A4
|
239.0 μm
STANDARD_DEVIATION 75.87 • n=37 Participants • Extended PPS-A4
|
240.5 μm
STANDARD_DEVIATION 64.17 • n=70 Participants • Extended PPS-A4
|
|
Lesion Thickness
|
20.3 μm
STANDARD_DEVIATION 37.90 • n=33 Participants • Extended PPS-A4
|
45.8 μm
STANDARD_DEVIATION 92.83 • n=37 Participants • Extended PPS-A4
|
33.8 μm
STANDARD_DEVIATION 72.99 • n=70 Participants • Extended PPS-A4
|
|
Subretinal Fluid-Foveal Involvement (SRFfi) Thickness
|
40.7 μm
STANDARD_DEVIATION 58.81 • n=33 Participants • Extended PPS-A4
|
25.0 μm
STANDARD_DEVIATION 50.76 • n=37 Participants • Extended PPS-A4
|
32.4 μm
STANDARD_DEVIATION 54.87 • n=70 Participants • Extended PPS-A4
|
|
Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness
|
60.9 μm
STANDARD_DEVIATION 92.26 • n=33 Participants • Extended PPS-A4
|
82.6 μm
STANDARD_DEVIATION 100.07 • n=37 Participants • Extended PPS-A4
|
72.4 μm
STANDARD_DEVIATION 96.39 • n=70 Participants • Extended PPS-A4
|
|
Total Lesion Size
|
6.1 mm^2
STANDARD_DEVIATION 4.73 • n=32 Participants • Extended PPS-A4
|
7.8 mm^2
STANDARD_DEVIATION 5.74 • n=35 Participants • Extended PPS-A4
|
7.0 mm^2
STANDARD_DEVIATION 5.31 • n=67 Participants • Extended PPS-A4
|
|
Choroidal Neovascularization (CNV) Size
|
6.0 mm^2
STANDARD_DEVIATION 4.79 • n=32 Participants • Extended PPS-A4
|
7.7 mm^2
STANDARD_DEVIATION 5.72 • n=35 Participants • Extended PPS-A4
|
6.9 mm^2
STANDARD_DEVIATION 5.33 • n=67 Participants • Extended PPS-A4
|
PRIMARY outcome
Timeframe: Day 84Population: Extended PPS-A4
For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84
|
25 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Day 14, Day 28, Day 56, Day 84Population: Extended PPS-A4 who required retreatment
The time was determined based on the visit of the treatment period when a patient was identified as requiring retreatment with LUCENTIS.
Outcome measures
| Measure |
LHA510
n=25 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=25 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Time to First LUCENTIS® Retreatment Need Identification up to Day 84
Day 14
|
0 Participants
|
0 Participants
|
|
Time to First LUCENTIS® Retreatment Need Identification up to Day 84
Day 28
|
5 Participants
|
8 Participants
|
|
Time to First LUCENTIS® Retreatment Need Identification up to Day 84
Day 56
|
16 Participants
|
11 Participants
|
|
Time to First LUCENTIS® Retreatment Need Identification up to Day 84
Day 84
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Day 84Population: Extended PPS-A4
The number of LUCENTIS retreatment needs identified before or at the Day 84 visit (even if retreatment was applied at a later visit) for each patient was used in the analysis
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84
0 retreatment injections
|
8 participants
|
12 participants
|
|
Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84
1 retreatment injection
|
18 participants
|
18 participants
|
|
Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84
2 retreatment injections
|
6 participants
|
6 participants
|
|
Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84
3 retreatment injections
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 28, Day 56Population: Extended PPS-A4
The number of LUCENTIS® retreatment needs identified before or at the Day 28 and Day 56 visits (even if retreatment was applied at a later visit) for each subject was used in the analysis.
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56
Day 28
|
5 Participants
|
8 Participants
|
|
Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56
Day 56
|
21 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day -1, Day 14, Day 28, Day 56, Day 84Population: Extended PPS-A4. Missing data imputed using the Last Observation Carried Forward (LOCF) approach.
The thickness of the retina was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site
Day 14
|
-46.9 μm
Standard Error 8.40
|
-43.0 μm
Standard Error 7.93
|
|
Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site
Day 28
|
-38.6 μm
Standard Error 7.42
|
-28.9 μm
Standard Error 7.00
|
|
Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site
Day 56
|
11.3 μm
Standard Error 10.01
|
1.0 μm
Standard Error 9.45
|
|
Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site
Day 84
|
-16.8 μm
Standard Error 8.92
|
-12.2 μm
Standard Error 8.42
|
SECONDARY outcome
Timeframe: Day -1, Day 14, Day 28, Day 56, Day 84Population: Extended PPS-A4. Missing Data Imputed Using LOCF.
Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity was conducted in each eye individually using ETDRS charts and reported in number of letters read correctly. An increase (gain) in letters read from the baseline assessment indicates improvement. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site
Day 56
|
-0.5 letters
Standard Error 1.28
|
2.3 letters
Standard Error 1.21
|
|
Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site
Day 14
|
1.3 letters
Standard Error 0.80
|
1.6 letters
Standard Error 0.75
|
|
Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site
Day 28
|
1.7 letters
Standard Error 0.89
|
2.5 letters
Standard Error 0.84
|
|
Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site
Day 84
|
-1.7 letters
Standard Error 1.59
|
2.2 letters
Standard Error 1.50
|
SECONDARY outcome
Timeframe: Day -1, Day 28, Day 84Population: Extended PPS-A4. Missing data imputed using LOCF.
The thickness of the neuro-retina, at the level of the central subfield, was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit
Day 28
|
-16.6 μm
Standard Deviation 22.62
|
-15.1 μm
Standard Deviation 38.21
|
|
Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit
Day 84
|
-4.1 μm
Standard Deviation 35.34
|
-8.8 μm
Standard Deviation 36.75
|
SECONDARY outcome
Timeframe: Day -1, Day 28, Day 84Population: Extended PPS-A4. Missing data imputed using LOCF.
The thickness of the neovascular lesion was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of the neovascular lesion may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Change From Randomization Visit (Day -1) in Lesion Thickness by Visit
Day 28
|
-1.9 μm
Standard Deviation 38.05
|
6.9 μm
Standard Deviation 43.66
|
|
Change From Randomization Visit (Day -1) in Lesion Thickness by Visit
Day 84
|
1.4 μm
Standard Deviation 26.46
|
6.9 μm
Standard Deviation 43.96
|
SECONDARY outcome
Timeframe: Day -1, Day 28, Day 84Population: Extended PPS-A4. Missing Data Imputed Using LOCF.
The thickness of subretinal fluid involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of subretinal fluid involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit
Day 28
|
-18.5 μm
Standard Deviation 44.67
|
-11.0 μm
Standard Deviation 34.73
|
|
Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit
Day 84
|
-14.1 μm
Standard Deviation 54.08
|
-5.9 μm
Standard Deviation 31.33
|
SECONDARY outcome
Timeframe: Day -1, Day 28, Day 84Population: Extended PPS-A4. Missing Data Imputed Using LOCF.
The thickness of pigment epithelial detachment involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of pigment epithelial detachment involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
LHA510
n=33 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=37 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit
Day 28
|
-0.3 μm
Standard Deviation 38.92
|
-13.3 μm
Standard Deviation 43.23
|
|
Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit
Day 84
|
-0.2 μm
Standard Deviation 33.33
|
-7.6 μm
Standard Deviation 47.25
|
SECONDARY outcome
Timeframe: Day -1, Day 84Population: Extended PPS-A4 as observed
The total wet AMD lesion size was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in wet AMD lesion size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
LHA510
n=32 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=35 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Change From Randomization Visit (Day -1) in Total Lesion Size by Visit
|
-0.3 mm^2
Standard Deviation 1.71
|
0.5 mm^2
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Day -1, Day 84Population: Extended PPS-A4 as observed
The size of CNV (area of new blood vessels in the choroid layer of the retina) was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in CNV size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
LHA510
n=32 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=35 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Change From Randomization Visit (Day -1) in CNV Size by Visit
|
-0.6 mm^2
Standard Deviation 2.00
|
0.5 mm^2
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Day 28, Day 84Population: This analysis population includes all subjects who were treated with LHA510, had at least 1 serum sample following exposure to the IP, and had no known specimen collection or analytical deviations, as identified by the Pharmacokineticist, that would have affected the integrity of the data \[Pharmacokinetics (PK) Analysis Set\].
Samples collected from subjects, after multiple topical ocular dosing of LHA510, were analyzed to determine concentrations of LHA510 and its metabolite, CRA398. Plasma LHA510 and CRA398 concentrations were quantitated by a validated liquid chromatography-tandem mass spectroscopy assay method. Below the limit of quantification (BLQ) is treated as zero.
Outcome measures
| Measure |
LHA510
n=31 Participants
LHA510 ophthalmic suspension administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
Vehicle
n=31 Participants
LHA510 vehicle administered topically in the study eye as specified in the protocol for 84 days, with ranibizumab ophthalmic solution for IVT injection as standard of care rescue therapy.
|
|---|---|---|
|
Plasma Concentration of LHA510 and CRA398
Day 28, BID
|
0.0746 ng/mL
Standard Deviation 0.0483
|
0.0257 ng/mL
Standard Deviation 0.0287
|
|
Plasma Concentration of LHA510 and CRA398
Day 84, QD
|
0.0403 ng/mL
Standard Deviation 0.0225
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentration of LHA510 and CRA398
Day 84, TID
|
0.0694 ng/mL
Standard Deviation 0.0439
|
0.0160 ng/mL
Standard Deviation 0.0179
|
Adverse Events
Pre-treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LHA510
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Post-treatment LHA510
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Post-treatment Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-treatment
n=136 participants at risk
All subjects with AE/s reported prior to the initiation of IP administration
|
LHA510
n=46 participants at risk
All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration
|
Vehicle
n=45 participants at risk
All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration
|
Post-treatment LHA510
n=46 participants at risk
All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
|
Post-treatment Vehicle
n=45 participants at risk
All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.2%
1/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.2%
1/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.2%
1/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.2%
1/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
Other adverse events
| Measure |
Pre-treatment
n=136 participants at risk
All subjects with AE/s reported prior to the initiation of IP administration
|
LHA510
n=46 participants at risk
All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration
|
Vehicle
n=45 participants at risk
All subjects with AE/s having an onset from IP initiation and up through 7 days after cessation of IP administration
|
Post-treatment LHA510
n=46 participants at risk
All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
|
Post-treatment Vehicle
n=45 participants at risk
All subjects with AE/s having an onset more than 7 days after IP administration cessation through the study exit
|
|---|---|---|---|---|---|
|
Eye disorders
Corneal oedema
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
17.4%
8/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
43.5%
20/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Eye irritation
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
10.9%
5/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
6.7%
3/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Eye pain
|
0.74%
1/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
6.5%
3/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Keratopathy
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
10.9%
5/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Vision blurred
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
13.0%
6/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.2%
1/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.2%
1/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
6.5%
3/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Investigations
Vital dye staining cornea present
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
8.7%
4/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
4.4%
2/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.2%
1/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/136 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
6.5%
3/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.2%
1/46 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/45 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 177 days). AEs are reported as pre-treatment, treatment-emergent, and post-treatment.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER