Trial Outcomes & Findings for A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model (NCT NCT03231969)
NCT ID: NCT03231969
Last Updated: 2023-03-16
Results Overview
The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).
Results posted on
2023-03-16
Participant Flow
Participant milestones
| Measure |
Bilastine 0.2%
Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0.4%
Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0.6%
Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0%
Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
31
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
Baseline characteristics by cohort
| Measure |
Bilastine 0.2%
n=30 Participants
Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0.4%
n=30 Participants
Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0.6%
n=31 Participants
Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0%
n=30 Participants
Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 13.95 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 13.24 • n=4 Participants
|
49.4 years
STANDARD_DEVIATION 12.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
102 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
31 participants
n=5 Participants
|
30 participants
n=4 Participants
|
121 participants
n=21 Participants
|
|
Ocular Itching- Baseline
Visit 4b: Pre- CAC
|
0.058 units on a scale
STANDARD_DEVIATION 0.2043 • n=5 Participants
|
0.000 units on a scale
STANDARD_DEVIATION 0.0000 • n=7 Participants
|
0.048 units on a scale
STANDARD_DEVIATION 0.1981 • n=5 Participants
|
0.025 units on a scale
STANDARD_DEVIATION 0.1006 • n=4 Participants
|
0.03275 units on a scale
STANDARD_DEVIATION 0.12575 • n=21 Participants
|
|
Ocular Itching- Baseline
Visit 5b: Pre- CAC
|
0.000 units on a scale
STANDARD_DEVIATION 0.0000 • n=5 Participants
|
0.000 units on a scale
STANDARD_DEVIATION 0.0000 • n=7 Participants
|
0.033 units on a scale
STANDARD_DEVIATION 0.1826 • n=5 Participants
|
0.033 units on a scale
STANDARD_DEVIATION 0.1826 • n=4 Participants
|
0.0165 units on a scale
STANDARD_DEVIATION 0.0913 • n=21 Participants
|
|
Ocular Itching- Baseline
Visit 6: Pre- CAC
|
0.000 units on a scale
STANDARD_DEVIATION 0.0000 • n=5 Participants
|
0.000 units on a scale
STANDARD_DEVIATION 0.0000 • n=7 Participants
|
0.000 units on a scale
STANDARD_DEVIATION 0.0000 • n=5 Participants
|
0.000 units on a scale
STANDARD_DEVIATION 0.0000 • n=4 Participants
|
0.000 units on a scale
STANDARD_DEVIATION 0.0000 • n=21 Participants
|
PRIMARY outcome
Timeframe: The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.
Outcome measures
| Measure |
Bilastine 0.2%
n=30 Participants
Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0.4%
n=30 Participants
Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0.6%
n=31 Participants
Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0% (Vehicle)
n=30 Participants
Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period
|
|---|---|---|---|---|
|
Ocular Itching
Visit 4b: 3 minutes Post-CAC
|
1.908 units on a scale
Standard Deviation 0.7809
|
1.925 units on a scale
Standard Deviation 0.9449
|
1.177 units on a scale
Standard Deviation 1.0332
|
2.758 units on a scale
Standard Deviation 0.7146
|
|
Ocular Itching
Visit 4b: 5 minutes Post-CAC
|
2.075 units on a scale
Standard Deviation 0.7828
|
2.117 units on a scale
Standard Deviation 0.9531
|
1.218 units on a scale
Standard Deviation 1.1268
|
3.017 units on a scale
Standard Deviation 0.5979
|
|
Ocular Itching
Visit 4b: 7 minutes Post-CAC
|
2.092 units on a scale
Standard Deviation 0.7698
|
2.100 units on a scale
Standard Deviation 1.0760
|
1.218 units on a scale
Standard Deviation 1.1157
|
2.917 units on a scale
Standard Deviation 0.5884
|
|
Ocular Itching
Visit 5b: 3 minutes Post-CAC
|
1.397 units on a scale
Standard Deviation 1.1050
|
1.250 units on a scale
Standard Deviation 0.8872
|
0.708 units on a scale
Standard Deviation 0.8908
|
2.558 units on a scale
Standard Deviation 0.8032
|
|
Ocular Itching
Visit 5b: 5 minutes Post-CAC
|
1.466 units on a scale
Standard Deviation 0.9300
|
1.464 units on a scale
Standard Deviation 0.9592
|
0.817 units on a scale
Standard Deviation 1.0503
|
2.642 units on a scale
Standard Deviation 0.7505
|
|
Ocular Itching
Visit 5b: 7 minutes Post-CAC
|
1.379 units on a scale
Standard Deviation 0.8573
|
1.518 units on a scale
Standard Deviation 1.0340
|
0.742 units on a scale
Standard Deviation 0.9837
|
2.642 units on a scale
Standard Deviation 0.7704
|
|
Ocular Itching
Visit 6: 3 minutes Post-CAC
|
0.679 units on a scale
Standard Deviation 0.6662
|
0.732 units on a scale
Standard Deviation 0.9127
|
0.392 units on a scale
Standard Deviation 0.5749
|
2.542 units on a scale
Standard Deviation 0.8384
|
|
Ocular Itching
Visit 6: 5 minutes Post-CAC
|
0.920 units on a scale
Standard Deviation 0.7235
|
1.143 units on a scale
Standard Deviation 0.9987
|
0.558 units on a scale
Standard Deviation 0.6355
|
2.592 units on a scale
Standard Deviation 0.8343
|
|
Ocular Itching
Visit 6: 7 minutes Post-CAC
|
1.000 units on a scale
Standard Deviation 0.7454
|
1.214 units on a scale
Standard Deviation 0.9421
|
0.583 units on a scale
Standard Deviation 0.6706
|
2.483 units on a scale
Standard Deviation 0.9024
|
Adverse Events
Bilastine 0.2%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Bilastine 0.4%
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Bilastine 0.6%
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bilastine 0%
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bilastine 0.2%
n=30 participants at risk
Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0.4%
n=30 participants at risk
Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0.6%
n=31 participants at risk
Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.
|
Bilastine 0%
n=30 participants at risk
Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.
|
|---|---|---|---|---|
|
Eye disorders
Visual Acuity Reduced
|
6.7%
2/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Eye disorders
Blepharitis
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Eye disorders
Corneal Deposits
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Eye disorders
Keratitis
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Eye disorders
Macular Fibrosis
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Infections and infestations
Hordeolum
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
10.0%
3/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
3.2%
1/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
General disorders
Pyrexia
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.3%
1/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/31 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
0.00%
0/30 • Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place