Trial Outcomes & Findings for Safety and IOP-Lowering Effects of WB007 (NCT NCT04149899)
NCT ID: NCT04149899
Last Updated: 2025-03-27
Results Overview
IOP is a measurement of the pressure inside the eye and was measured using Goldmann applanation tonometry. Study participants used the study medications in both eyes for 14 days. One eye was designated as the Study Eye at baseline: eyes that met inclusion and exclusion criteria. If both eyes were eligible, the study eye was the eye with higher IOP at Baseline at Hour 0. If both eyes had the same IOP at this timepoint, the right eye was designated as the study eye. IOP was measured at Baseline and Day 14 at Hours 0, 2, 4 and 8. The primary endpoint was the mean change from baseline IOP at Day 14, Hour 2, the timepoint of the peak effect of timolol.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Baseline, Day 14
Results posted on
2025-03-27
Participant Flow
This was a 2-part study: Part 1: 18 subjects were enrolled and completed study. Based on results from Part 1, two WB007 doses were selected for Part 2. Part 2: 59 subjects were enrolled and completed the study. No subjects discontinued the study.
Participant milestones
| Measure |
Part 1 (Period 1): WB007 0.05%
WB007 0.05%, single dose to study eye on Day 1
|
Part 1 (Period 2): WB007 0.15%
WB007 0.15%, single dose to study eye on Day 1
|
Part 1 (Period 3): WB007 0.4%
WB007 0.4%, single dose to study eye on Day 1
|
Part 2: WB007 0.15%
WB007 0.15%, dosed twice daily for 14 days
|
Part 2: WB007 0.4%
WB007 0.4%, dosed twice daily for 14 days
|
Part 2: Timolol 0.5%
Timolol 0.5%, dosed twice daily for 14 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
23
|
24
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
23
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and IOP-Lowering Effects of WB007
Baseline characteristics by cohort
| Measure |
Part 1 (Period 1): WB007 0.05%
n=6 Participants
WB007 0.05%, single dose to study eye on Day 1
|
Part 1 (Period 2): WB007 0.15%
n=6 Participants
WB007 0.15%, single dose to study eye on Day 1
|
Part 1 (Period 3): WB007 0.4%
n=6 Participants
WB007 0.4%, single dose to study eye on Day 1
|
Part 2: WB007 0.15%
n=23 Participants
WB007 0.15% dosed twice daily for 14 days
|
Part 2: WB007 0.4%
n=24 Participants
WB007 0.4% dosed twice daily for 14 days
|
Part 2: Timolol 0.5%
n=12 Participants
Timolol 0.5%, dosed twice daily for 14 days
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 12.44 • n=5 Participants
|
71.2 years
STANDARD_DEVIATION 4.79 • n=7 Participants
|
77.5 years
STANDARD_DEVIATION 4.85 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 12.88 • n=4 Participants
|
69.0 years
STANDARD_DEVIATION 13.40 • n=21 Participants
|
64.8 years
STANDARD_DEVIATION 13.37 • n=10 Participants
|
68.8 years
STANDARD_DEVIATION 12.30 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
62 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
23 participants
n=4 Participants
|
24 participants
n=21 Participants
|
12 participants
n=10 Participants
|
77 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 14Population: Modified Intent-to-Treat Population (mITT) with Last Observation Carried Forward: the mITT population consisted of all randomized and treated subjects who provided IOP data at baseline and had at least one post-baseline IOP assessment.
IOP is a measurement of the pressure inside the eye and was measured using Goldmann applanation tonometry. Study participants used the study medications in both eyes for 14 days. One eye was designated as the Study Eye at baseline: eyes that met inclusion and exclusion criteria. If both eyes were eligible, the study eye was the eye with higher IOP at Baseline at Hour 0. If both eyes had the same IOP at this timepoint, the right eye was designated as the study eye. IOP was measured at Baseline and Day 14 at Hours 0, 2, 4 and 8. The primary endpoint was the mean change from baseline IOP at Day 14, Hour 2, the timepoint of the peak effect of timolol.
Outcome measures
| Measure |
Part 2: WB007 0.15%
n=23 Participants
WB007 0.15%, dosed twice daily for 14 days.
|
Part 2: WB007 0.4%
n=24 Participants
WB007 0.4%, dosed twice daily for 14 days.
|
Part 2: Timolol 0.5%
n=12 Participants
Timolol 0.5%, dosed twice daily for 14 days.
|
|---|---|---|---|
|
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Baseline Hour 0
|
26.3 millimeters of mercury (mm Hg)
Standard Deviation 2.13
|
26.1 millimeters of mercury (mm Hg)
Standard Deviation 2.17
|
27.1 millimeters of mercury (mm Hg)
Standard Deviation 3.53
|
|
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Baseline Hour 2
|
24.8 millimeters of mercury (mm Hg)
Standard Deviation 2.59
|
24.8 millimeters of mercury (mm Hg)
Standard Deviation 2.16
|
26.7 millimeters of mercury (mm Hg)
Standard Deviation 4.29
|
|
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Baseline Hour 4
|
25.0 millimeters of mercury (mm Hg)
Standard Deviation 2.66
|
24.8 millimeters of mercury (mm Hg)
Standard Deviation 2.27
|
25.8 millimeters of mercury (mm Hg)
Standard Deviation 4.50
|
|
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Baseline Hour 8
|
24.3 millimeters of mercury (mm Hg)
Standard Deviation 2.60
|
23.9 millimeters of mercury (mm Hg)
Standard Deviation 2.00
|
26.1 millimeters of mercury (mm Hg)
Standard Deviation 4.85
|
|
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Day 14 Hour 0
|
-2.6 millimeters of mercury (mm Hg)
Standard Deviation 2.56
|
-3.3 millimeters of mercury (mm Hg)
Standard Deviation 2.55
|
-5.3 millimeters of mercury (mm Hg)
Standard Deviation 2.93
|
|
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Day 14 Hour 2
|
-4.9 millimeters of mercury (mm Hg)
Standard Deviation 1.85
|
-5.1 millimeters of mercury (mm Hg)
Standard Deviation 2.51
|
-6.0 millimeters of mercury (mm Hg)
Standard Deviation 3.05
|
|
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Day 14 Hour 4
|
-4.3 millimeters of mercury (mm Hg)
Standard Deviation 1.98
|
-3.6 millimeters of mercury (mm Hg)
Standard Deviation 2.94
|
-4.0 millimeters of mercury (mm Hg)
Standard Deviation 3.41
|
|
Part 2: Mean Change From Baseline in Intraocular Pressure (IOP) at Day 14 - Study Eye
Day 14 Hour 8
|
-1.8 millimeters of mercury (mm Hg)
Standard Deviation 2.08
|
-1.8 millimeters of mercury (mm Hg)
Standard Deviation 2.88
|
-5.5 millimeters of mercury (mm Hg)
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Baseline, Day 14Population: Modified Intent-to-Treat Population (mITT) with Last Observation Carried Forward: the mITT population consisted of all randomized and treated subjects who provided IOP data at baseline and had at least one post-baseline IOP assessment.
IOP is a measurement of the pressure inside the eye and was measured using Goldmann applanation tonometry. Study participants used the study medications in both eyes for 14 days. One eye was designated as the Study Eye at baseline: eyes that met inclusion and exclusion criteria. If both eyes were eligible, the study eye was the eye with higher IOP at Baseline at Hour 0. If both eyes had the same IOP at this timepoint, the right eye was designated as the study eye. IOP was measured at Baseline and Day 14 at Hours 0, 2, 4 and 8. The primary timepoint was at Day 14, Hour 2, the timepoint of the peak effect of timolol.
Outcome measures
| Measure |
Part 2: WB007 0.15%
n=23 Participants
WB007 0.15%, dosed twice daily for 14 days.
|
Part 2: WB007 0.4%
n=24 Participants
WB007 0.4%, dosed twice daily for 14 days.
|
Part 2: Timolol 0.5%
n=12 Participants
Timolol 0.5%, dosed twice daily for 14 days.
|
|---|---|---|---|
|
Part 2: Mean IOP at Day 14 - Study Eye
Day 14, Hour 4
|
20.7 millimeters of mercury (mm Hg)
Standard Deviation 3.10
|
21.2 millimeters of mercury (mm Hg)
Standard Deviation 2.89
|
21.8 millimeters of mercury (mm Hg)
Standard Deviation 3.22
|
|
Part 2: Mean IOP at Day 14 - Study Eye
Day 14, Hour 8
|
22.6 millimeters of mercury (mm Hg)
Standard Deviation 3.74
|
22.1 millimeters of mercury (mm Hg)
Standard Deviation 2.52
|
20.6 millimeters of mercury (mm Hg)
Standard Deviation 3.66
|
|
Part 2: Mean IOP at Day 14 - Study Eye
Baseline, Hour 0
|
26.3 millimeters of mercury (mm Hg)
Standard Deviation 2.13
|
26.1 millimeters of mercury (mm Hg)
Standard Deviation 2.17
|
27.1 millimeters of mercury (mm Hg)
Standard Deviation 3.53
|
|
Part 2: Mean IOP at Day 14 - Study Eye
Baseline, Hour 2
|
24.8 millimeters of mercury (mm Hg)
Standard Deviation 2.59
|
24.8 millimeters of mercury (mm Hg)
Standard Deviation 2.16
|
26.7 millimeters of mercury (mm Hg)
Standard Deviation 4.29
|
|
Part 2: Mean IOP at Day 14 - Study Eye
Baseline, Hour 4
|
25.0 millimeters of mercury (mm Hg)
Standard Deviation 2.66
|
24.8 millimeters of mercury (mm Hg)
Standard Deviation 2.27
|
25.8 millimeters of mercury (mm Hg)
Standard Deviation 4.50
|
|
Part 2: Mean IOP at Day 14 - Study Eye
Baseline, Hour 8
|
24.3 millimeters of mercury (mm Hg)
Standard Deviation 2.60
|
23.9 millimeters of mercury (mm Hg)
Standard Deviation 2.00
|
26.1 millimeters of mercury (mm Hg)
Standard Deviation 4.85
|
|
Part 2: Mean IOP at Day 14 - Study Eye
Day 14, Hour 0
|
23.7 millimeters of mercury (mm Hg)
Standard Deviation 3.83
|
22.9 millimeters of mercury (mm Hg)
Standard Deviation 2.42
|
21.8 millimeters of mercury (mm Hg)
Standard Deviation 1.64
|
|
Part 2: Mean IOP at Day 14 - Study Eye
Day 14, Hour 2
|
19.9 millimeters of mercury (mm Hg)
Standard Deviation 2.47
|
19.7 millimeters of mercury (mm Hg)
Standard Deviation 1.83
|
20.7 millimeters of mercury (mm Hg)
Standard Deviation 2.18
|
Adverse Events
Part 1 (Period 1): WB007 0.05%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 (Period 2): WB007 0.15%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 (Period 3): WB007 0.4%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: WB007 0.15%
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Part 2: WB007 0.4%
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part 2: Timolol 0.5%
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 (Period 1): WB007 0.05%
n=6 participants at risk
WB007 0.05%, single dose to study eye on Day 1
|
Part 1 (Period 2): WB007 0.15%
n=6 participants at risk
WB007 0.15%, single dose to study eye on Day 1
|
Part 1 (Period 3): WB007 0.4%
n=6 participants at risk
WB007 0.4%, single dose to study eye on Day 1
|
Part 2: WB007 0.15%
n=23 participants at risk
WB007 0.15%, dosed twice daily for 14 days
|
Part 2: WB007 0.4%
n=24 participants at risk
WB007 0.4%, dosed twice daily for 14 days
|
Part 2: Timolol 0.5%
n=12 participants at risk
Timolol 0.5%, dosed twice daily for 14 days
|
|---|---|---|---|---|---|---|
|
General disorders
Instillation Site Pain
|
0.00%
0/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
0.00%
0/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
0.00%
0/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
43.5%
10/23 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
50.0%
12/24 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
8.3%
1/12 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
|
General disorders
Instillation Site Burn
|
0.00%
0/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
0.00%
0/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
0.00%
0/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
8.7%
2/23 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
16.7%
4/24 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
0.00%
0/12 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
0.00%
0/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
83.3%
5/6 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
30.4%
7/23 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
33.3%
8/24 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
8.3%
1/12 • Screening up to Baseline (up to 6 weeks) Part 1: Post-Baseline to Day 2 Part 2: Post-Baseline to Day 14
Adverse Events are reported for all treated subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall agree to submit all manuscripts or abstracts to the sponsor for review before submission. Authorship and manuscript composition will reflect joint cooperation between the investigator(s) and sponsor personnel; authorship will be established by mutual agreement, and in line with ICMJE authorship requirements. No individual publications will be allowed prior to completion of the final report of the multicenter study, except as agreed with sponsor.
- Publication restrictions are in place
Restriction type: OTHER