Trial Outcomes & Findings for A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model. (NCT NCT03479307)
NCT ID: NCT03479307
Last Updated: 2023-03-16
Results Overview
The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
228 participants
Primary outcome timeframe
The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).
Results posted on
2023-03-16
Participant Flow
Participant milestones
| Measure |
Bilastine Ophthalmic Solution 0.6%
Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period.
|
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
|
Vehicle of Bilastine Ophthalmic Solution
Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
90
|
47
|
|
Overall Study
COMPLETED
|
90
|
89
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Baseline characteristics by cohort
| Measure |
Bilastine Ophthalmic Solution 0.6%
n=91 Participants
Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period.
|
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
n=90 Participants
Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
|
Vehicle of Bilastine Ophthalmic Solution
n=47 Participants
Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 12.88 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 16.03 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 13.38 • n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
90 participants
n=7 Participants
|
47 participants
n=5 Participants
|
228 participants
n=4 Participants
|
|
Ocular Itching- Baseline
Visit 4b: Pre-CAC
|
0.014 units on a scale
STANDARD_DEVIATION 0.0945 • n=5 Participants
|
0.011 units on a scale
STANDARD_DEVIATION 0.1054 • n=7 Participants
|
0.043 units on a scale
STANDARD_DEVIATION 0.2949 • n=5 Participants
|
0.023 units on a scale
STANDARD_DEVIATION 0.1649 • n=4 Participants
|
|
Ocular Itching- Baseline
Visit 5: 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
|
PRIMARY outcome
Timeframe: The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub).
Outcome measures
| Measure |
Bilastine Ophthalmic Solution 0.6%
n=91 Participants
Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period.
|
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
n=90 Participants
Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
|
Vehicle of Bilastine Ophthalmic Solution
n=47 Participants
Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
|
|---|---|---|---|
|
Ocular Itching
Visit 4b: 3 minutes Post- CAC
|
1.609 units on a scale
Standard Deviation 0.9013
|
1.886 units on a scale
Standard Deviation 0.9504
|
2.219 units on a scale
Standard Deviation 0.9644
|
|
Ocular Itching
Visit 4b: 5 minutes Post- CAC
|
1.750 units on a scale
Standard Deviation 0.9508
|
1.919 units on a scale
Standard Deviation 0.9670
|
2.490 units on a scale
Standard Deviation 0.8996
|
|
Ocular Itching
Visit 4b: 7 minutes Post- CAC
|
1.747 units on a scale
Standard Deviation 1.0283
|
1.894 units on a scale
Standard Deviation 0.9606
|
2.526 units on a scale
Standard Deviation 0.9035
|
|
Ocular Itching
Visit 5: 3 minutes Post- CAC
|
0.669 units on a scale
Standard Deviation 0.7926
|
0.658 units on a scale
Standard Deviation 0.6745
|
1.840 units on a scale
Standard Deviation 0.9258
|
|
Ocular Itching
Visit 5: 5 minutes Post- CAC
|
0.828 units on a scale
Standard Deviation 0.8879
|
0.902 units on a scale
Standard Deviation 0.8208
|
2.011 units on a scale
Standard Deviation 0.9058
|
|
Ocular Itching
Visit 5: 7 minutes Post- CAC
|
0.826 units on a scale
Standard Deviation 0.8901
|
0.981 units on a scale
Standard Deviation 0.9224
|
1.931 units on a scale
Standard Deviation 0.8703
|
Adverse Events
Bilastine Ophthalmic Solution 0.6%
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vehicle of Bilastine Ophthalmic Solution
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bilastine Ophthalmic Solution 0.6%
n=91 participants at risk
Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period.
|
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
n=90 participants at risk
Ketotifen Ophthalmic Solution 0.025% (Zaditen): 1 drop in each eye at 2 separate times during an 8 day period.
|
Vehicle of Bilastine Ophthalmic Solution
n=47 participants at risk
Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period.
|
|---|---|---|---|
|
Eye disorders
Visual Acuty Reduced
|
3.3%
3/91 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
0.00%
0/90 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
0.00%
0/47 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/91 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
1.1%
1/90 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
0.00%
0/47 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/91 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
1.1%
1/90 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
0.00%
0/47 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
|
Infections and infestations
Sinusitis
|
1.1%
1/91 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
0.00%
0/90 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
0.00%
0/47 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/91 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
0.00%
0/90 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
2.1%
1/47 • Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place