Allergic Conjunctivitis
Conditions
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.
Interventions
DRUGBilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.
DRUGKetotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period.
DRUGVehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period.
Sponsors
ORA, Inc.
Faes Farma, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilastine Ophthalmic Solution 0.6% Bilastine Ophthalmic Solution 0.6%: 1 drop in each eye at 2 separate times during an 8 day period. | 91 |
| 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. | 90 |
| Vehicle of Bilastine Ophthalmic Solution Vehicle of Bilastine Ophthalmic Solution: 1 drop in each eye at 2 separate times during an 8 day period. | 47 |
| Total | 228 |
Baseline characteristics
| Characteristic | Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Vehicle of Bilastine Ophthalmic Solution | Bilastine Ophthalmic Solution 0.6% | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 43 Participants | 85 Participants | 217 Participants |
| Age, Continuous | 41.7 years STANDARD_DEVIATION 12.1 | 45.1 years STANDARD_DEVIATION 16.03 | 45.9 years STANDARD_DEVIATION 12.88 | 44.1 years STANDARD_DEVIATION 13.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 6 Participants | 11 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 41 Participants | 80 Participants | 200 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ocular Itching- Baseline Visit 4b: Pre-CAC | 0.011 units on a scale STANDARD_DEVIATION 0.1054 | 0.043 units on a scale STANDARD_DEVIATION 0.2949 | 0.014 units on a scale STANDARD_DEVIATION 0.0945 | 0.023 units on a scale STANDARD_DEVIATION 0.1649 |
| Ocular Itching- Baseline Visit 5: Pre-CAC | 0.000 units on a scale STANDARD_DEVIATION 0 | 0.000 units on a scale STANDARD_DEVIATION 0 | 0.000 units on a scale STANDARD_DEVIATION 0 | 0.000 units on a scale STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 6 Participants | 14 Participants | 33 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 14 Participants | 25 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 26 Participants | 49 Participants | 123 Participants |
| Region of Enrollment United States | 90 participants | 47 participants | 91 participants | 228 participants |
| Sex: Female, Male Female | 53 Participants | 25 Participants | 58 Participants | 136 Participants |
| Sex: Female, Male Male | 37 Participants | 22 Participants | 33 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 90 | 0 / 47 |
| other Total, other adverse events | 4 / 91 | 2 / 90 | 1 / 47 |
| serious Total, serious adverse events | 0 / 91 | 0 / 90 | 0 / 47 |
Outcome results
Primary
Ocular Itching
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilastine Ophthalmic Solution 0.6% | Ocular Itching | Visit 4b: 3 minutes Post- CAC | 1.609 units on a scale | Standard Deviation 0.9013 |
| Bilastine Ophthalmic Solution 0.6% | Ocular Itching | Visit 4b: 5 minutes Post- CAC | 1.750 units on a scale | Standard Deviation 0.9508 |
| Bilastine Ophthalmic Solution 0.6% | Ocular Itching | Visit 4b: 7 minutes Post- CAC | 1.747 units on a scale | Standard Deviation 1.0283 |
| Bilastine Ophthalmic Solution 0.6% | Ocular Itching | Visit 5: 3 minutes Post- CAC | 0.669 units on a scale | Standard Deviation 0.7926 |
| Bilastine Ophthalmic Solution 0.6% | Ocular Itching | Visit 5: 5 minutes Post- CAC | 0.828 units on a scale | Standard Deviation 0.8879 |
| Bilastine Ophthalmic Solution 0.6% | Ocular Itching | Visit 5: 7 minutes Post- CAC | 0.826 units on a scale | Standard Deviation 0.8901 |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Ocular Itching | Visit 5: 7 minutes Post- CAC | 0.981 units on a scale | Standard Deviation 0.9224 |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Ocular Itching | Visit 4b: 3 minutes Post- CAC | 1.886 units on a scale | Standard Deviation 0.9504 |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Ocular Itching | Visit 5: 3 minutes Post- CAC | 0.658 units on a scale | Standard Deviation 0.6745 |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Ocular Itching | Visit 5: 5 minutes Post- CAC | 0.902 units on a scale | Standard Deviation 0.8208 |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Ocular Itching | Visit 4b: 5 minutes Post- CAC | 1.919 units on a scale | Standard Deviation 0.967 |
| Ketotifen Ophthalmic Solution 0.025% (Zaditen) | Ocular Itching | Visit 4b: 7 minutes Post- CAC | 1.894 units on a scale | Standard Deviation 0.9606 |
| Vehicle of Bilastine Ophthalmic Solution | Ocular Itching | Visit 4b: 5 minutes Post- CAC | 2.490 units on a scale | Standard Deviation 0.8996 |
| Vehicle of Bilastine Ophthalmic Solution | Ocular Itching | Visit 4b: 7 minutes Post- CAC | 2.526 units on a scale | Standard Deviation 0.9035 |
| Vehicle of Bilastine Ophthalmic Solution | Ocular Itching | Visit 5: 7 minutes Post- CAC | 1.931 units on a scale | Standard Deviation 0.8703 |
| Vehicle of Bilastine Ophthalmic Solution | Ocular Itching | Visit 5: 3 minutes Post- CAC | 1.840 units on a scale | Standard Deviation 0.9258 |
| Vehicle of Bilastine Ophthalmic Solution | Ocular Itching | Visit 4b: 3 minutes Post- CAC | 2.219 units on a scale | Standard Deviation 0.9644 |
| Vehicle of Bilastine Ophthalmic Solution | Ocular Itching | Visit 5: 5 minutes Post- CAC | 2.011 units on a scale | Standard Deviation 0.9058 |
Comparison: Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 4b (including all time points).p-value: <0.000195% CI: [-1.013, -0.407]ANCOVA
Comparison: Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).p-value: <0.000195% CI: [-1.439, -0.895]ANCOVA
Comparison: 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).p-value: <0.000195% CI: [-1.413, -0.868]ANCOVA
Comparison: 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).p-value: 0.0007ANCOVA
Comparison: 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).p-value: 0.0002ANCOVA
Comparison: 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).p-value: <0.0001ANCOVA