Allergic Conjunctivitis
Conditions
Brief summary
To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis
Interventions
DRUGBilastine 0.2%
1 drop in each eye at 3 separate times during a 25 day period.
DRUGBilastine 0.4%
1 drop in each eye at 3 separate times during a 25 day period.
DRUGBilastine 0.6%
1 drop in each eye at 3 separate times during a 25 day period.
DRUGBilastine 0%
1 drop in each eye at 3 separate times during a 25 day period.
Sponsors
ORA, Inc.
Faes Farma, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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 Key
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), 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilastine 0.2% Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period. | 30 |
| Bilastine 0.4% Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period. | 30 |
| Bilastine 0.6% Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period. | 31 |
| Bilastine 0% Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period. | 30 |
| Total | 121 |
Baseline characteristics
| Characteristic | Bilastine 0.2% | Bilastine 0.4% | Bilastine 0.6% | Bilastine 0% | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 27 Participants | 27 Participants | 27 Participants | 109 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 10.7 | 47.0 years STANDARD_DEVIATION 13.95 | 51.8 years STANDARD_DEVIATION 13.4 | 48.3 years STANDARD_DEVIATION 13.24 | 49.4 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants | 5 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 23 Participants | 27 Participants | 25 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ocular Itching- Baseline Visit 4b: Pre- CAC | 0.058 units on a scale STANDARD_DEVIATION 0.2043 | 0.000 units on a scale STANDARD_DEVIATION 0 | 0.048 units on a scale STANDARD_DEVIATION 0.1981 | 0.025 units on a scale STANDARD_DEVIATION 0.1006 | 0.03275 units on a scale STANDARD_DEVIATION 0.12575 |
| Ocular Itching- Baseline Visit 5b: Pre- CAC | 0.000 units on a scale STANDARD_DEVIATION 0 | 0.000 units on a scale STANDARD_DEVIATION 0 | 0.033 units on a scale STANDARD_DEVIATION 0.1826 | 0.033 units on a scale STANDARD_DEVIATION 0.1826 | 0.0165 units on a scale STANDARD_DEVIATION 0.0913 |
| Ocular Itching- Baseline Visit 6: 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 | 0.000 units on a scale STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 4 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 27 Participants | 26 Participants | 27 Participants | 107 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 31 participants | 30 participants | 121 participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 15 Participants | 17 Participants | 66 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 16 Participants | 13 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 8 / 30 | 3 / 30 | 1 / 31 | 7 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 31 | 0 / 30 |
Outcome results
Primary
Ocular Itching
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilastine 0.2% | Ocular Itching | Visit 6: 3 minutes Post-CAC | 0.679 units on a scale | Standard Deviation 0.6662 |
| Bilastine 0.2% | Ocular Itching | Visit 5b: 7 minutes Post-CAC | 1.379 units on a scale | Standard Deviation 0.8573 |
| Bilastine 0.2% | Ocular Itching | Visit 6: 7 minutes Post-CAC | 1.000 units on a scale | Standard Deviation 0.7454 |
| Bilastine 0.2% | Ocular Itching | Visit 5b: 3 minutes Post-CAC | 1.397 units on a scale | Standard Deviation 1.105 |
| Bilastine 0.2% | Ocular Itching | Visit 4b: 7 minutes Post-CAC | 2.092 units on a scale | Standard Deviation 0.7698 |
| Bilastine 0.2% | Ocular Itching | Visit 4b: 5 minutes Post-CAC | 2.075 units on a scale | Standard Deviation 0.7828 |
| Bilastine 0.2% | Ocular Itching | Visit 6: 5 minutes Post-CAC | 0.920 units on a scale | Standard Deviation 0.7235 |
| Bilastine 0.2% | Ocular Itching | Visit 5b: 5 minutes Post-CAC | 1.466 units on a scale | Standard Deviation 0.93 |
| Bilastine 0.2% | Ocular Itching | Visit 4b: 3 minutes Post-CAC | 1.908 units on a scale | Standard Deviation 0.7809 |
| Bilastine 0.4% | Ocular Itching | Visit 5b: 5 minutes Post-CAC | 1.464 units on a scale | Standard Deviation 0.9592 |
| Bilastine 0.4% | Ocular Itching | Visit 6: 3 minutes Post-CAC | 0.732 units on a scale | Standard Deviation 0.9127 |
| Bilastine 0.4% | Ocular Itching | Visit 5b: 7 minutes Post-CAC | 1.518 units on a scale | Standard Deviation 1.034 |
| Bilastine 0.4% | Ocular Itching | Visit 4b: 5 minutes Post-CAC | 2.117 units on a scale | Standard Deviation 0.9531 |
| Bilastine 0.4% | Ocular Itching | Visit 4b: 3 minutes Post-CAC | 1.925 units on a scale | Standard Deviation 0.9449 |
| Bilastine 0.4% | Ocular Itching | Visit 4b: 7 minutes Post-CAC | 2.100 units on a scale | Standard Deviation 1.076 |
| Bilastine 0.4% | Ocular Itching | Visit 6: 7 minutes Post-CAC | 1.214 units on a scale | Standard Deviation 0.9421 |
| Bilastine 0.4% | Ocular Itching | Visit 6: 5 minutes Post-CAC | 1.143 units on a scale | Standard Deviation 0.9987 |
| Bilastine 0.4% | Ocular Itching | Visit 5b: 3 minutes Post-CAC | 1.250 units on a scale | Standard Deviation 0.8872 |
| Bilastine 0.6% | Ocular Itching | Visit 5b: 5 minutes Post-CAC | 0.817 units on a scale | Standard Deviation 1.0503 |
| Bilastine 0.6% | Ocular Itching | Visit 4b: 3 minutes Post-CAC | 1.177 units on a scale | Standard Deviation 1.0332 |
| Bilastine 0.6% | Ocular Itching | Visit 4b: 5 minutes Post-CAC | 1.218 units on a scale | Standard Deviation 1.1268 |
| Bilastine 0.6% | Ocular Itching | Visit 4b: 7 minutes Post-CAC | 1.218 units on a scale | Standard Deviation 1.1157 |
| Bilastine 0.6% | Ocular Itching | Visit 5b: 3 minutes Post-CAC | 0.708 units on a scale | Standard Deviation 0.8908 |
| Bilastine 0.6% | Ocular Itching | Visit 5b: 7 minutes Post-CAC | 0.742 units on a scale | Standard Deviation 0.9837 |
| Bilastine 0.6% | Ocular Itching | Visit 6: 3 minutes Post-CAC | 0.392 units on a scale | Standard Deviation 0.5749 |
| Bilastine 0.6% | Ocular Itching | Visit 6: 5 minutes Post-CAC | 0.558 units on a scale | Standard Deviation 0.6355 |
| Bilastine 0.6% | Ocular Itching | Visit 6: 7 minutes Post-CAC | 0.583 units on a scale | Standard Deviation 0.6706 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 6: 3 minutes Post-CAC | 2.542 units on a scale | Standard Deviation 0.8384 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 5b: 3 minutes Post-CAC | 2.558 units on a scale | Standard Deviation 0.8032 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 4b: 7 minutes Post-CAC | 2.917 units on a scale | Standard Deviation 0.5884 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 6: 7 minutes Post-CAC | 2.483 units on a scale | Standard Deviation 0.9024 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 6: 5 minutes Post-CAC | 2.592 units on a scale | Standard Deviation 0.8343 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 4b: 5 minutes Post-CAC | 3.017 units on a scale | Standard Deviation 0.5979 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 5b: 7 minutes Post-CAC | 2.642 units on a scale | Standard Deviation 0.7704 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 5b: 5 minutes Post-CAC | 2.642 units on a scale | Standard Deviation 0.7505 |
| Bilastine 0% (Vehicle) | Ocular Itching | Visit 4b: 3 minutes Post-CAC | 2.758 units on a scale | Standard Deviation 0.7146 |
Comparison: Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).p-value: 0.000295% CI: [-1.203, -0.378]ANCOVA
Comparison: Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).p-value: <0.000195% CI: [-1.263, -0.439]ANCOVA
Comparison: Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).p-value: <0.000195% CI: [-1.954, -1.135]ANCOVA
Comparison: Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).p-value: <0.000195% CI: [-1.639, -0.778]ANCOVA
Comparison: Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).p-value: <0.000195% CI: [-1.679, -0.811]ANCOVA
Comparison: Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).p-value: <0.000195% CI: [-2.273, -1.418]ANCOVA
Comparison: Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).p-value: <0.000195% CI: [-2.08, -1.312]ANCOVA
Comparison: Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).p-value: <0.000195% CI: [-2.001, -1.232]ANCOVA
Comparison: Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).p-value: <0.000195% CI: [-2.387, -1.63]ANCOVA