A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Study Details
Study Description
Brief Summary
To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Bilastine Ophthalmic Solution 0.6% Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period. |
Drug: Bilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.
|
Active Comparator: 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. |
Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period.
Other Names:
|
Placebo Comparator: Vehicle of Bilastine Ophthalmic Solution Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period. |
Drug: Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period.
|
Outcome Measures
Primary Outcome Measures
- Ocular Itching [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
be at least 18 years old
-
be willing and able to avoid all disallowed medications and contact lenses
-
must have a pregnancy test if of childbearing potential
-
must be able to read an eye chart from 10 feet away
Exclusion Criteria:
-
must not have any allergies to the study medications
-
must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
-
must not have used immunotherapy in the last 2 years
-
must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cornea Consultants of AZ | Phoenix | Arizona | United States | 85032 |
2 | East West Eye Institute | Torrance | California | United States | 90505 |
3 | Andover Eye Associates | Andover | Massachusetts | United States | 01810 |
4 | Apex Eye | Mason | Ohio | United States | 45040 |
5 | Philadelphia Eye Associates | Philadelphia | Pennsylvania | United States | 19134 |
6 | Total Eye Care, P.A. | Memphis | Tennessee | United States | 38119 |
Sponsors and Collaborators
- Faes Farma, S.A.
- ORA, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- BOFT-0218/AC-CAC
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Bilastine Ophthalmic Solution 0.6% | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Vehicle of Bilastine Ophthalmic Solution |
---|---|---|---|
Arm/Group Description | 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): 1 drop in each eye at 2 separate times during an 8 day period. | Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. |
Period Title: Overall Study | |||
STARTED | 91 | 90 | 47 |
COMPLETED | 90 | 89 | 47 |
NOT COMPLETED | 1 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Bilastine Ophthalmic Solution 0.6% | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Vehicle of Bilastine Ophthalmic Solution | Total |
---|---|---|---|---|
Arm/Group Description | 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): 1 drop in each eye at 2 separate times during an 8 day period. | Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. | Total of all reporting groups |
Overall Participants | 91 | 90 | 47 | 228 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
85
93.4%
|
89
98.9%
|
43
91.5%
|
217
95.2%
|
>=65 years |
6
6.6%
|
1
1.1%
|
4
8.5%
|
11
4.8%
|
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
45.9
(12.88)
|
41.7
(12.1)
|
45.1
(16.03)
|
44.1
(13.38)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
58
63.7%
|
53
58.9%
|
25
53.2%
|
136
59.6%
|
Male |
33
36.3%
|
37
41.1%
|
22
46.8%
|
92
40.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
11
12.1%
|
10
11.1%
|
6
12.8%
|
27
11.8%
|
Not Hispanic or Latino |
80
87.9%
|
79
87.8%
|
41
87.2%
|
200
87.7%
|
Unknown or Not Reported |
0
0%
|
1
1.1%
|
0
0%
|
1
0.4%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
1
1.1%
|
1
1.1%
|
1
2.1%
|
3
1.3%
|
Asian |
14
15.4%
|
13
14.4%
|
6
12.8%
|
33
14.5%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
25
27.5%
|
27
30%
|
14
29.8%
|
66
28.9%
|
White |
49
53.8%
|
48
53.3%
|
26
55.3%
|
123
53.9%
|
More than one race |
2
2.2%
|
1
1.1%
|
0
0%
|
3
1.3%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | ||||
United States |
91
100%
|
90
100%
|
47
100%
|
228
100%
|
Ocular Itching- Baseline (units on a scale) [Mean (Standard Deviation) ] | ||||
Visit 4b: Pre-CAC |
0.014
(0.0945)
|
0.011
(0.1054)
|
0.043
(0.2949)
|
0.023
(0.1649)
|
Visit 5: Pre-CAC |
0.000
(0.0000)
|
0.000
(0.0000)
|
0.000
(0.0000)
|
0.000
(0.0000)
|
Outcome Measures
Title | Ocular Itching |
---|---|
Description | 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). |
Time Frame | The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment). |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Bilastine Ophthalmic Solution 0.6% | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Vehicle of Bilastine Ophthalmic Solution |
---|---|---|---|
Arm/Group Description | 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): 1 drop in each eye at 2 separate times during an 8 day period. | Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. |
Measure Participants | 91 | 90 | 47 |
Visit 4b: 3 minutes Post- CAC |
1.609
(0.9013)
|
1.886
(0.9504)
|
2.219
(0.9644)
|
Visit 4b: 5 minutes Post- CAC |
1.750
(0.9508)
|
1.919
(0.9670)
|
2.490
(0.8996)
|
Visit 4b: 7 minutes Post- CAC |
1.747
(1.0283)
|
1.894
(0.9606)
|
2.526
(0.9035)
|
Visit 5: 3 minutes Post- CAC |
0.669
(0.7926)
|
0.658
(0.6745)
|
1.840
(0.9258)
|
Visit 5: 5 minutes Post- CAC |
0.828
(0.8879)
|
0.902
(0.8208)
|
2.011
(0.9058)
|
Visit 5: 7 minutes Post- CAC |
0.826
(0.8901)
|
0.981
(0.9224)
|
1.931
(0.8703)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bilastine Ophthalmic Solution 0.6%, Vehicle of Bilastine Ophthalmic Solution |
---|---|---|
Comments | Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 4b (including all time points). | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.0001 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.710 | |
Confidence Interval |
(2-Sided) 95% -1.013 to -0.407 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Bilastine Ophthalmic Solution 0.6%, Vehicle of Bilastine Ophthalmic Solution |
---|---|---|
Comments | Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points). | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.0001 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -1.167 | |
Confidence Interval |
(2-Sided) 95% -1.439 to -0.895 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Ketotifen Ophthalmic Solution 0.025% (Zaditen), Vehicle of Bilastine Ophthalmic Solution |
---|---|---|
Comments | Treatment Difference (95% CI): Ketotifen Ophthalmic Solution 0.025% (Zaditen) arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points). | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | < 0.0001 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -1.140 | |
Confidence Interval |
(2-Sided) 95% -1.413 to -0.868 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen) |
---|---|---|
Comments | Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 3 minutes Post-CAC (non-inferiority test). | |
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority margin of 0.40 | |
Statistical Test of Hypothesis | p-Value | 0.0007 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.009 | |
Confidence Interval |
(1-Sided) 97.5% to 0.235 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 5
Statistical Analysis Overview | Comparison Group Selection | Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen) |
---|---|---|
Comments | Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 5 minutes Post-CAC (non-inferiority test). | |
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority margin of 0.40 | |
Statistical Test of Hypothesis | p-Value | 0.0002 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.077 | |
Confidence Interval |
(1-Sided) 97.5% to 0.175 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 6
Statistical Analysis Overview | Comparison Group Selection | Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen) |
---|---|---|
Comments | Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 7 minutes Post-CAC (non-inferiority test). | |
Type of Statistical Test | Non-Inferiority | |
Comments | Non-inferiority margin of 0.40 | |
Statistical Test of Hypothesis | p-Value | < 0.0001 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.159 | |
Confidence Interval |
(1-Sided) 97.5% to 0.101 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | Safety assessment period (Day 1 through Day 8): Adverse events were assessed at all office visits, throughout a period of 8 days. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Bilastine Ophthalmic Solution 0.6% | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Vehicle of Bilastine Ophthalmic Solution | |||
Arm/Group Description | 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): 1 drop in each eye at 2 separate times during an 8 day period. | Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. | |||
All Cause Mortality |
||||||
Bilastine Ophthalmic Solution 0.6% | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Vehicle of Bilastine Ophthalmic Solution | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/91 (0%) | 0/90 (0%) | 0/47 (0%) | |||
Serious Adverse Events |
||||||
Bilastine Ophthalmic Solution 0.6% | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Vehicle of Bilastine Ophthalmic Solution | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/91 (0%) | 0/90 (0%) | 0/47 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Bilastine Ophthalmic Solution 0.6% | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Vehicle of Bilastine Ophthalmic Solution | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/91 (4.4%) | 2/90 (2.2%) | 1/47 (2.1%) | |||
Eye disorders | ||||||
Visual Acuty Reduced | 3/91 (3.3%) | 0/90 (0%) | 0/47 (0%) | |||
Infections and infestations | ||||||
Conjunctivitis | 0/91 (0%) | 1/90 (1.1%) | 0/47 (0%) | |||
Hordeolum | 0/91 (0%) | 1/90 (1.1%) | 0/47 (0%) | |||
Sinusitis | 1/91 (1.1%) | 0/90 (0%) | 0/47 (0%) | |||
Tooth Abscess | 0/91 (0%) | 0/90 (0%) | 1/47 (2.1%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Nieves Fernández, MD, PhD |
---|---|
Organization | Faes Farma |
Phone | +34 94 481 83 00 |
nfernandez@faes.es |
- BOFT-0218/AC-CAC