Trial Outcomes & Findings for Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (NCT NCT04742283)
NCT ID: NCT04742283
Last Updated: 2023-06-22
Results Overview
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
323 participants
Primary outcome timeframe
08:00, 10:00 and 16:00 at Week 2
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Timolol Maleate Opthalmic Solution 0.5% BID
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
162
|
|
Overall Study
COMPLETED
|
148
|
158
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Timolol Maleate Opthalmic Solution 0.5% BID
n=161 Participants
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
n=162 Participants
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 11.63 • n=99 Participants
|
66.2 years
STANDARD_DEVIATION 10.24 • n=107 Participants
|
65.9 years
STANDARD_DEVIATION 10.95 • n=206 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
116 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
236 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
43 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 08:00, 10:00 and 16:00 at Week 2Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Outcome measures
| Measure |
Timolol Maleate Opthalmic Solution 0.5% BID
n=159 Participants
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
n=161 Participants
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
|---|---|---|
|
Intraocular Pressure at Week 2
8:00
|
19.05 mmHg
Standard Error 0.242
|
18.92 mmHg
Standard Error 0.239
|
|
Intraocular Pressure at Week 2
10:00
|
18.28 mmHg
Standard Error 0.219
|
17.86 mmHg
Standard Error 0.216
|
|
Intraocular Pressure at Week 2
16:00
|
17.91 mmHg
Standard Error 0.215
|
17.15 mmHg
Standard Error 0.212
|
PRIMARY outcome
Timeframe: 08:00, 10:00 and 16:00 at Week 6Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Outcome measures
| Measure |
Timolol Maleate Opthalmic Solution 0.5% BID
n=159 Participants
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
n=161 Participants
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
|---|---|---|
|
Intraocular Pressure at Week 6
8:00
|
18.72 mmHg
Standard Error 0.238
|
18.32 mmHg
Standard Error 0.233
|
|
Intraocular Pressure at Week 6
10:00
|
18.29 mmHg
Standard Error 0.238
|
17.96 mmHg
Standard Error 0.233
|
|
Intraocular Pressure at Week 6
16:00
|
18.24 mmHg
Standard Error 0.235
|
17.52 mmHg
Standard Error 0.229
|
PRIMARY outcome
Timeframe: 08:00, 10:00 and 16:00 at Month 3Population: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.
Intraocular pressure (IOP), the fluid pressure inside the eye was measure by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day. Analysis using Mixed-effects Model for Repeated Measures (MMRM).
Outcome measures
| Measure |
Timolol Maleate Opthalmic Solution 0.5% BID
n=159 Participants
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
n=161 Participants
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
|---|---|---|
|
Intraocular Pressure at Month 3
8:00
|
18.78 mmHg
Standard Error 0.249
|
18.80 mmHg
Standard Error 0.244
|
|
Intraocular Pressure at Month 3
10:00
|
18.12 mmHg
Standard Error 0.244
|
18.07 mmHg
Standard Error 0.239
|
|
Intraocular Pressure at Month 3
16:00
|
18.52 mmHg
Standard Error 0.228
|
17.57 mmHg
Standard Error 0.223
|
SECONDARY outcome
Timeframe: Three monthsPopulation: The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of the study medication (test or control medication) and had at least one post-baseline efficacy assessment of the study eye during the study.
Mean diurnal Intraocular Pressure (IOP) was defined as the mean of the IOP valued at the three schedules timepoints (8:00, 10:00 and 16:00) at that visit for that subject.
Outcome measures
| Measure |
Timolol Maleate Opthalmic Solution 0.5% BID
n=159 Participants
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
n=161 Participants
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
|---|---|---|
|
Mean Diurnal Intraocular Pressure at Month 3
|
18.43 mmHg
Standard Error 0.209
|
18.15 mmHg
Standard Error 0.205
|
Adverse Events
Timolol Maleate Opthalmic Solution 0.5% BID
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Timolol Maleate Opthalmic Solution 0.5% BID
n=160 participants at risk
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
n=161 participants at risk
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • Number of events 1 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.62%
1/160 • Number of events 1 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.62%
1/160 • Number of events 1 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
Syncope
|
0.62%
1/160 • Number of events 1 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Vascular disorders
Hypertension
|
0.62%
1/160 • Number of events 1 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
Other adverse events
| Measure |
Timolol Maleate Opthalmic Solution 0.5% BID
n=160 participants at risk
Timolol Maleate Ophthalmic Solution 0.5% is administered twice daily (BID)
Timolol Maleate Ophthalmic Solution 0.5% BID: Timolol Maleate Ophthalmic Solution BID (morning and evening)
|
DE-126 Opthalmic Solution 0.002% QD and Vehicle QD
n=161 participants at risk
DE-126 Ophthalmic Solution 0.002% is administered once daily (QD)
DE-126 Ophthalmic Solution 0.002% QD: DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
2.5%
4/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
9.9%
16/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Eye pruritus
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
2.5%
4/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Eye pain
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
1.9%
3/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Dry eye
|
1.2%
2/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
1.2%
2/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
1.2%
2/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Ocular hyperaemia
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
1.2%
2/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Chalazion
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Eye irritation
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Eyelash thickening
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Eyelid margin crusting
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Scintillating scotoma
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Anterior chamber cell
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Anterior chamber flare
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Lacrimation increased
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Macular fibrosis
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Eye disorders
Vision blurred
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
General disorders
Fatigue
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
General disorders
Instillation site pain
|
3.8%
6/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
General disorders
Instillation site pruritus
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
General disorders
Asthenia
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
General disorders
Drug intolerance
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
1.2%
2/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Infections and infestations
COVID-19
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Infections and infestations
Onychomycosis
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Infections and infestations
Tooth infection
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Investigations
Vital dye staining cornea present
|
1.2%
2/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Immune system disorders
Food allergy
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
Headache
|
1.2%
2/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.62%
1/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Psychiatric disorders
Depression
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
Breast mass
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.62%
1/160 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
0.00%
0/161 • From informed consent to until subject withdrawal or study exit at month 3 including two weeks of follow up after last study drug administration.
Treatment emergent adverse events were summarized for the safety population. The Safety population will include all randomized subjects who received at least one dose of the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place