Conjunctivitis, Allergic
Conditions
Brief summary
The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis
Interventions
DRUGBepreve
sterile ophthalmic solution
DRUGPlacebo
sterile ophthalmic solution
sterile ophthalmic solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 10 years of age & either sex, any race * Willing and able to follow all instructions and attend all study visits * Positive history of ocular allergies
Exclusion criteria
* Have planned surgery during trial period * Female currently pregnant, planning a pregnancy, or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching | 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub |
| Conjunctival Redness | 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemosis | 15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely Severe-Overall ballooning of conjunctiva |
| Rhinorrhea (Runny Nose) | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose |
| Nasal Pruritus (Itchy Nose) | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub |
| Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub |
| Ciliary Redness | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade |
| Tearing | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Percent of Eyes with Tearing. Scored as absent or present |
| Ocular Mucus Discharge | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present |
| Eyelid Swelling | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids |
| Total Nasal Symptom | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Total Nasal Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe |
| Nasal Congestion | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model | Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked |
| Episcleral Redness | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points | 35 |
| Placebo 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points | 36 |
| Bepotastine Besilate Ophthalmic Solution 1.0% 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points | 36 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Subject met exclusion criteria | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Bepotastine Besilate Ophthalmic Solution 1.0% | Placebo | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% |
|---|---|---|---|---|
| Age Continuous | 41.7 years STANDARD_DEVIATION 14.3 | 39.9 years STANDARD_DEVIATION 15.2 | 40.9 years STANDARD_DEVIATION 11.4 | 44.3 years STANDARD_DEVIATION 16 |
| Age, Customized <18 years | 7 participants | 3 participants | 2 participants | 2 participants |
| Age, Customized >=18 years | 100 participants | 33 participants | 34 participants | 33 participants |
| Sex: Female, Male Female | 49 Participants | 14 Participants | 17 Participants | 18 Participants |
| Sex: Female, Male Male | 58 Participants | 22 Participants | 19 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 35 | 2 / 36 | 8 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 | 0 / 36 |
Outcome results
Primary
Conjunctival Redness
Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade
Time frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 16 Hours post-dose: 20 minutes post CAC | 1.8 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 8 Hours post-dose: 20 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 8 Hours post-dose: 7 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 16 Hours post-dose: 15 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 8 Hours post-dose: 15 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 15 Minutes post-dose: 15 Minutes post CAC | 1.7 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 15 Minutes post-dose: 7 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 16 Hours post-dose: 7 Minutes post CAC | 1.7 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Conjunctival Redness | 15 Minutes post-dose: 20 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.8 |
| Placebo | Conjunctival Redness | 16 Hours post-dose: 20 minutes post CAC | 1.7 Units on a scale | Standard Deviation 0.6 |
| Placebo | Conjunctival Redness | 15 Minutes post-dose: 7 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Conjunctival Redness | 15 Minutes post-dose: 15 Minutes post CAC | 2.1 Units on a scale | Standard Deviation 0.6 |
| Placebo | Conjunctival Redness | 15 Minutes post-dose: 20 Minutes post CAC | 2.0 Units on a scale | Standard Deviation 0.6 |
| Placebo | Conjunctival Redness | 8 Hours post-dose: 7 Minutes post CAC | 1.7 Units on a scale | Standard Deviation 0.7 |
| Placebo | Conjunctival Redness | 8 Hours post-dose: 15 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Conjunctival Redness | 8 Hours post-dose: 20 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.7 |
| Placebo | Conjunctival Redness | 16 Hours post-dose: 7 Minutes post CAC | 1.8 Units on a scale | Standard Deviation 0.6 |
| Placebo | Conjunctival Redness | 16 Hours post-dose: 15 Minutes post CAC | 1.8 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 16 Hours post-dose: 20 minutes post CAC | 1.5 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 8 Hours post-dose: 20 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 15 Minutes post-dose: 15 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 16 Hours post-dose: 15 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 16 Hours post-dose: 7 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 8 Hours post-dose: 7 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 15 Minutes post-dose: 7 Minutes post CAC | 1.1 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 8 Hours post-dose: 15 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Conjunctival Redness | 15 Minutes post-dose: 20 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 0.7 |
Primary
Ocular Itching
Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub
Time frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 8 Hours post-dose: 3 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 16 Hours post-dose: 7 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 8 Hours post-dose: 7 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 8 Hours post-dose: 5 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 15 Minutes post-dose: 3 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 16 Hours post-dose: 5 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 1.1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 15 Minutes post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 15 Minutes post-dose: 5 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Itching | 16 Hours post-dose: 3 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 1 |
| Placebo | Ocular Itching | 8 Hours post-dose: 5 Minutes post CAC | 2.3 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ocular Itching | 15 Minutes post-dose: 3 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.8 |
| Placebo | Ocular Itching | 15 Minutes post-dose: 5 Minutes post CAC | 2.1 Units on a scale | Standard Deviation 0.8 |
| Placebo | Ocular Itching | 15 Minutes post-dose: 7 Minutes post CAC | 2.0 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ocular Itching | 8 Hours post-dose: 3 Minutes post CAC | 2.0 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ocular Itching | 8 Hours post-dose: 7 Minutes post CAC | 2.2 Units on a scale | Standard Deviation 0.8 |
| Placebo | Ocular Itching | 16 Hours post-dose: 3 Minutes post CAC | 2.1 Units on a scale | Standard Deviation 0.9 |
| Placebo | Ocular Itching | 16 Hours post-dose: 5 Minutes post CAC | 2.4 Units on a scale | Standard Deviation 0.8 |
| Placebo | Ocular Itching | 16 Hours post-dose: 7 Minutes post CAC | 2.3 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 15 Minutes post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 15 Minutes post-dose: 3 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 16 Hours post-dose: 3 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 15 Minutes post-dose: 5 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 16 Hours post-dose: 7 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 1 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 8 Hours post-dose: 5 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 8 Hours post-dose: 3 Minutes post CAC | 1.2 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 16 Hours post-dose: 5 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.9 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Itching | 8 Hours post-dose: 7 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 0.8 |
Secondary
Chemosis
Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely Severe-Overall ballooning of conjunctiva
Time frame: 15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 8 Hours post-dose: 7 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 16 Hours post-dose: 20 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 8 Hours psot-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 8 Hours post-dose: 15 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 15 Minutes post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.3 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 16 Hours post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 15 Minutes post-dose: 20 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.3 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 15 Minutes post-dose: 15 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Chemosis | 16 Hours post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.5 |
| Placebo | Chemosis | 8 Hours post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Chemosis | 15 Minutes post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.5 |
| Placebo | Chemosis | 15 Minutes post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Chemosis | 15 Minutes post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.6 |
| Placebo | Chemosis | 8 Hours post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.5 |
| Placebo | Chemosis | 8 Hours psot-dose: 20 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Chemosis | 16 Hours post-dose: 7 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.4 |
| Placebo | Chemosis | 16 Hours post-dose: 15 Minutes post CAC | 1.1 Units on a scale | Standard Deviation 0.5 |
| Placebo | Chemosis | 16 Hours post-dose: 20 Minutes post CAC | 1.1 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 15 Minutes post-dose: 20 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.3 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 15 Minutes post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.3 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 16 Hours post-dose: 7 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.4 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 15 Minutes post-dose: 15 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.3 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 16 Hours post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 8 Hours post-dose: 15 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.4 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 8 Hours post-dose: 7 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.4 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 16 Hours post-dose: 15 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.4 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Chemosis | 8 Hours psot-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.4 |
Secondary
Ciliary Redness
Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 8 Hours post-dose: 7 Minute post CAC | 1.2 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 16 Hours post-dose: 20 Minute post CAC | 1.7 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 8 Hours post-dose: 20 Minute post CAC | 1.4 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 8 Hours post-dose: 15 Minute post CAC | 1.5 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 15 Minutes post-dose: 7 Minute post CAC | 1.2 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 16 Hours post-dose: 15 Minute post CAC | 1.9 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 15 Minutes post-dose: 20 Minute post CAC | 1.6 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 15 Minutes post-dose: 15 Minute post CAC | 1.5 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ciliary Redness | 16 Hours post-dose: 7 Minute post CAC | 1.6 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ciliary Redness | 8 Hours post-dose: 15 Minute post CAC | 1.7 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ciliary Redness | 15 Minutes post-dose: 7 Minute post CAC | 1.7 Units on a scale | Standard Deviation 0.6 |
| Placebo | Ciliary Redness | 15 Minutes post-dose: 15 Minute post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Ciliary Redness | 15 Minutes post-dose: 20 Minute post CAC | 1.8 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ciliary Redness | 8 Hours post-dose: 7 Minute post CAC | 1.5 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ciliary Redness | 8 Hours post-dose: 20 Minute post CAC | 1.7 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ciliary Redness | 16 Hours post-dose: 7 Minute post CAC | 1.7 Units on a scale | Standard Deviation 0.6 |
| Placebo | Ciliary Redness | 16 Hours post-dose: 15 Minute post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Ciliary Redness | 16 Hours post-dose: 20 Minute post CAC | 1.8 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 15 Minutes post-dose: 20 Minute post CAC | 1.3 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 15 Minutes post-dose: 7 Minute post CAC | 0.9 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 16 Hours post-dose: 7 Minute post CAC | 1.3 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 15 Minutes post-dose: 15 Minute post CAC | 1.3 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 16 Hours post-dose: 20 Minute post CAC | 1.4 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 8 Hours post-dose: 15 Minute post CAC | 1.5 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 8 Hours post-dose: 7 Minute post CAC | 1.2 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 16 Hours post-dose: 15 Minute post CAC | 1.5 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ciliary Redness | 8 Hours post-dose: 20 Minute post CAC | 1.4 Units on a scale | Standard Deviation 0.8 |
Secondary
Ear or Palate Pruritus (Itchy Ear or Palate)
Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 7 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 20 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 15 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 15 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 20 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 15 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 7 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.7 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 15 Minutes post CAC | 1.2 Units on a scale | Standard Deviation 1.2 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 7 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.9 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 20 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 7 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.9 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 20 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1.1 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 7 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.9 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 15 Minutes post CAC | 1.0 Units on a scale | Standard Deviation 1.2 |
| Placebo | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 20 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1.2 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 7 Minutes post CAC | 0.1 Units on a scale | Standard Deviation 0.2 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 15 Minutes post-dose: 15 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1.1 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 15 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 16 Hours post-dose: 15 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1.2 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ear or Palate Pruritus (Itchy Ear or Palate) | 8 Hours post-dose: 20 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.9 |
Secondary
Episcleral Redness
Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely Severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 16 Hours post-dose: 15 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 8 Hours post-dose: 20 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 15 Minutes post-dose: 15 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 16 Hours post-dose: 7 Minutes post CAC | 1.8 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 15 Minutes post-dose: 7 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 8 Hours post-dose: 7 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 16 Hours post-cose: 20 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 8 Hours post-dose: 15 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Episcleral Redness | 15 Minutes post-dose: 20 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.8 |
| Placebo | Episcleral Redness | 15 Minutes post-dose: 15 Minutes post CAC | 2.1 Units on a scale | Standard Deviation 0.6 |
| Placebo | Episcleral Redness | 15 Minutes post-dose: 20 Minutes post CAC | 2.0 Units on a scale | Standard Deviation 0.7 |
| Placebo | Episcleral Redness | 8 Hours post-dose: 15 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Episcleral Redness | 8 Hours post-dose: 20 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.7 |
| Placebo | Episcleral Redness | 16 Hours post-dose: 7 Minutes post CAC | 2.0 Units on a scale | Standard Deviation 0.5 |
| Placebo | Episcleral Redness | 16 Hours post-dose: 15 Minutes post CAC | 2.0 Units on a scale | Standard Deviation 0.5 |
| Placebo | Episcleral Redness | 16 Hours post-cose: 20 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Episcleral Redness | 15 Minutes post-dose: 7 Minutes post CAC | 1.9 Units on a scale | Standard Deviation 0.6 |
| Placebo | Episcleral Redness | 8 Hours post-dose: 7 Minutes post CAC | 1.7 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 16 Hours post-dose: 15 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 8 Hours post-dose: 7 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 15 Minutes post-dose: 7 Minutes post CAC | 1.1 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 16 Hours post-cose: 20 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 8 Hours post-dose: 20 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 15 Minutes post-dose: 20 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 16 Hours post-dose: 7 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 8 Hours post-dose: 15 Minutes post CAC | 1.7 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Episcleral Redness | 15 Minutes post-dose: 15 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 0.7 |
Secondary
Eyelid Swelling
Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 8 Hours post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 16 Hours post-dose: 20 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 8 Hours post-dose: 20 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 8 Hours post-dose: 15 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 15 Minutes post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 16 Hours post-dose: 15 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 15 Minutes post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 15 Minutes post-dose: 15 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Eyelid Swelling | 16 Hours post-dose: 7 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.6 |
| Placebo | Eyelid Swelling | 8 Hours post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.9 |
| Placebo | Eyelid Swelling | 15 Minutes post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.7 |
| Placebo | Eyelid Swelling | 15 Minutes post-dose: 15 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.7 |
| Placebo | Eyelid Swelling | 15 Minutes post-dose: 20 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.7 |
| Placebo | Eyelid Swelling | 8 Hours post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.7 |
| Placebo | Eyelid Swelling | 8 Hours post-dose: 20 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.9 |
| Placebo | Eyelid Swelling | 16 Hours post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.7 |
| Placebo | Eyelid Swelling | 16 Hours post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.9 |
| Placebo | Eyelid Swelling | 16 Hours post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 15 Minutes post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 15 Minutes post-dose: 7 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 16 Hours post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 15 Minutes post-dose: 15 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 16 Hours post-dose: 20 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 8 Hours post-dose: 15 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 8 Hours post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 16 Hours post-dose: 15 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Eyelid Swelling | 8 Hours post-dose: 20 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.6 |
Secondary
Nasal Congestion
Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 8 Hours post-dose: 7 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 16 Hours post-dose: 20 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 8 Hours post-dose: 20 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 8 Hours post-dose: 15 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 15 Minutes post-dose: 7 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 16 Hours post-dose: 15 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 15 Minutes post-dose: 20 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 15 Minutes post-dose: 15 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Congestion | 16 Hours post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.7 |
| Placebo | Nasal Congestion | 8 Hours post-dose: 15 Minutes post CAC | 1.2 Units on a scale | Standard Deviation 1.2 |
| Placebo | Nasal Congestion | 15 Minutes post-dose: 7 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1 |
| Placebo | Nasal Congestion | 15 Minutes post-dose: 15 Minutes post CAC | 1.1 Units on a scale | Standard Deviation 1.2 |
| Placebo | Nasal Congestion | 15 Minutes post-dose: 20 Minutes post CAC | 1.2 Units on a scale | Standard Deviation 1.1 |
| Placebo | Nasal Congestion | 8 Hours post-dose: 7 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1 |
| Placebo | Nasal Congestion | 8 Hours post-dose: 20 Minutes post CAC | 1.1 Units on a scale | Standard Deviation 1.2 |
| Placebo | Nasal Congestion | 16 Hours post-dose: 7 Minutes post CAC | 1.0 Units on a scale | Standard Deviation 1 |
| Placebo | Nasal Congestion | 16 Hours post-dose: 15 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 1.1 |
| Placebo | Nasal Congestion | 16 Hours post-dose: 20 Minutes post CAC | 1.2 Units on a scale | Standard Deviation 1.2 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 15 Minutes post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 15 Minutes post-dose: 7 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.4 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 16 Hours post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 15 Minutes post-dose: 15 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 16 Hours post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 8 Hours post-dose: 15 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 8 Hours post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 16 Hours post-dose: 15 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Congestion | 8 Hours post-dose: 20 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.7 |
Secondary
Nasal Pruritus (Itchy Nose)
Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 7 Minutes post CAC | 0.1 Units on a scale | Standard Deviation 0.4 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 20 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 15 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.7 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 15 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 20 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 15 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 7 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.7 |
| Placebo | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1.1 |
| Placebo | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.8 |
| Placebo | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 0.8 |
| Placebo | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 20 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.8 |
| Placebo | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 7 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.9 |
| Placebo | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1.1 |
| Placebo | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 7 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1 |
| Placebo | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1.1 |
| Placebo | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1.1 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 7 Minutes post CAC | 0.1 Units on a scale | Standard Deviation 0.3 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 15 Minutes post-dose: 15 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 20 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 15 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 16 Hours post-dose: 15 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Nasal Pruritus (Itchy Nose) | 8 Hours post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
Secondary
Ocular Mucus Discharge
Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 8 Hours post-dose: 7 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 16 Hours post-dose: 20 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 8 Hours post-dose: 20 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 8 Hours post-dose: 15 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 15 Minutes post-dose: 7 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 16 Hours post-dose: 15 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 15 Minutes post-dose: 20 Minutes post CAC | 2.9 Percent of Eyes with OMD Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 15 Minutes post-dose: 15 Minutes post CAC | 2.9 Percent of Eyes with OMD Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Mucus Discharge | 16 Hours post-dose: 7 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 8 Hours post-dose: 15 Minutes post CAC | 2.8 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 15 Minutes post-dose: 7 Minutes post CAC | 1.4 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 15 Minutes post-dose: 15 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 15 Minutes post-dose: 20 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 8 Hours post-dose: 7 Minutes post CAC | 1.4 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 8 Hours post-dose: 20 Minutes post CAC | 2.8 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 16 Hours post-dose: 7 Minutes post CAC | 2.8 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 16 Hours post-dose: 15 Minutes post CAC | 5.6 Percent of Eyes with OMD Present |
| Placebo | Ocular Mucus Discharge | 16 Hours post-dose: 20 Minutes post CAC | 5.6 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 15 Minutes post-dose: 20 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 15 Minutes post-dose: 7 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 16 Hours post-dose: 7 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 15 Minutes post-dose: 15 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 16 Hours post-dose: 20 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 8 Hours post-dose: 15 Minutes post CAC | 1.4 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 8 Hours post-dose: 7 Minutes post CAC | 1.4 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 16 Hours post-dose: 15 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Ocular Mucus Discharge | 8 Hours post-dose: 20 Minutes post CAC | 0.0 Percent of Eyes with OMD Present |
Secondary
Rhinorrhea (Runny Nose)
Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 7 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.5 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 20 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 15 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 15 Minutes post CAC | 0.6 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 20 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 15 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.7 |
| Placebo | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 15 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 1.2 |
| Placebo | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 7 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1 |
| Placebo | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 15 Minutes post CAC | 1.1 Units on a scale | Standard Deviation 1 |
| Placebo | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 20 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1.1 |
| Placebo | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 7 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1 |
| Placebo | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 20 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 1.3 |
| Placebo | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 7 Minutes post CAC | 1.0 Units on a scale | Standard Deviation 1 |
| Placebo | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 15 Minutes post CAC | 1.4 Units on a scale | Standard Deviation 1.1 |
| Placebo | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 20 Minutes post CAC | 1.2 Units on a scale | Standard Deviation 1.2 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 20 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 7 Minutes post CAC | 0.1 Units on a scale | Standard Deviation 0.3 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 15 Minutes post-dose: 15 Minutes post CAC | 0.2 Units on a scale | Standard Deviation 0.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 20 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 1 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 15 Minutes post CAC | 0.5 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 7 Minutes post CAC | 0.3 Units on a scale | Standard Deviation 0.7 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 16 Hours post-dose: 15 Minutes post CAC | 0.8 Units on a scale | Standard Deviation 0.9 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Rhinorrhea (Runny Nose) | 8 Hours post-dose: 20 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.7 |
Secondary
Tearing
Percent of Eyes with Tearing. Scored as absent or present
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 8 Hours post-dose: 7 Minutes post CAC | 12.9 Percent of Eyes with Tearing Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 16 Hours post-dose: 20 Minutes post CAC | 15.7 Percent of Eyes with Tearing Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 8 Hours post-dose: 20 Minutes post CAC | 12.9 Percent of Eyes with Tearing Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 8 Hours post-dose: 15 Minutes post CAC | 14.3 Percent of Eyes with Tearing Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 15 Minutes post-dose: 7 Minutes post CAC | 14.3 Percent of Eyes with Tearing Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 16 Hours post-dose: 15 Minutes post CAC | 15.7 Percent of Eyes with Tearing Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 15 Minutes post-dose: 20 Minutes post CAC | 17.1 Percent of Eyes with Tearing Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 15 Minutes post-dose: 15 Minutes post CAC | 17.1 Percent of Eyes with Tearing Present |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Tearing | 16 Hours post-dose: 7 Minutes post CAC | 11.4 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 8 Hours post-dose: 15 Minutes post CAC | 56.9 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 15 Minutes post-dose: 7 Minutes post CAC | 43.1 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 15 Minutes post-dose: 15 Minutes post CAC | 34.7 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 15 Minutes post-dose: 20 Minutes post CAC | 38.9 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 8 Hours post-dose: 7 Minutes post CAC | 50.0 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 8 Hours post-dose: 20 Minutes post CAC | 40.3 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 16 Hours post-dose: 7 Minutes post CAC | 43.1 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 16 Hours post-dose: 15 Minutes post CAC | 44.4 Percent of Eyes with Tearing Present |
| Placebo | Tearing | 16 Hours post-dose: 20 Minutes post CAC | 34.7 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 15 Minutes post-dose: 20 Minutes post CAC | 11.1 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 15 Minutes post-dose: 7 Minutes post CAC | 6.9 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 16 Hours post-dose: 7 Minutes post CAC | 23.6 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 15 Minutes post-dose: 15 Minutes post CAC | 9.7 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 16 Hours post-dose: 20 Minutes post CAC | 23.6 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 8 Hours post-dose: 15 Minutes post CAC | 16.7 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 8 Hours post-dose: 7 Minutes post CAC | 13.9 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 16 Hours post-dose: 15 Minutes post CAC | 19.4 Percent of Eyes with Tearing Present |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Tearing | 8 Hours post-dose: 20 Minutes post CAC | 15.3 Percent of Eyes with Tearing Present |
Secondary
Total Nasal Symptom
Total Nasal Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 8 Hours post-dose: 7 Minutes post CAC | 0.7 Units on a scale | Standard Deviation 1.6 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 16 Hours post-dose: 20 Minutes post CAC | 2.6 Units on a scale | Standard Deviation 3.1 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 8 Hours post-dose: 20 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 2.4 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 8 Hours post-dose: 15 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 2.2 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 15 Minutes post-dose: 7 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 2.2 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 16 Hours post-dose: 15 Minutes post CAC | 2.5 Units on a scale | Standard Deviation 2.9 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 15 Minutes post-dose: 20 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 2.2 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 15 Minutes post-dose: 15 Minutes post CAC | 1.7 Units on a scale | Standard Deviation 2.2 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Total Nasal Symptom | 16 Hours post-dose: 7 Minutes post CAC | 1.8 Units on a scale | Standard Deviation 2 |
| Placebo | Total Nasal Symptom | 8 Hours post-dose: 15 Minutes post CAC | 4.8 Units on a scale | Standard Deviation 4 |
| Placebo | Total Nasal Symptom | 15 Minutes post-dose: 7 Minutes post CAC | 3.2 Units on a scale | Standard Deviation 3.1 |
| Placebo | Total Nasal Symptom | 15 Minutes post-dose: 15 Minutes post CAC | 4.0 Units on a scale | Standard Deviation 3.4 |
| Placebo | Total Nasal Symptom | 15 Minutes post-dose: 20 Minutes post CAC | 3.6 Units on a scale | Standard Deviation 3.2 |
| Placebo | Total Nasal Symptom | 8 Hours post-dose: 7 Minutes post CAC | 2.9 Units on a scale | Standard Deviation 3.1 |
| Placebo | Total Nasal Symptom | 8 Hours post-dose: 20 Minutes post CAC | 4.0 Units on a scale | Standard Deviation 4 |
| Placebo | Total Nasal Symptom | 16 Hours post-dose: 7 Minutes post CAC | 3.4 Units on a scale | Standard Deviation 3.2 |
| Placebo | Total Nasal Symptom | 16 Hours post-dose: 15 Minutes post CAC | 4.5 Units on a scale | Standard Deviation 4 |
| Placebo | Total Nasal Symptom | 16 Hours post-dose: 20 Minutes post CAC | 4.0 Units on a scale | Standard Deviation 4.3 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 15 Minutes post-dose: 20 Minutes post CAC | 1.0 Units on a scale | Standard Deviation 1.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 15 Minutes post-dose: 7 Minutes post CAC | 0.4 Units on a scale | Standard Deviation 0.8 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 16 Hours post-dose: 7 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 2.6 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 15 Minutes post-dose: 15 Minutes post CAC | 0.9 Units on a scale | Standard Deviation 1.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 16 Hours post-dose: 20 Minutes post CAC | 2.8 Units on a scale | Standard Deviation 3.3 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 8 Hours post-dose: 15 Minutes post CAC | 1.6 Units on a scale | Standard Deviation 2.5 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 8 Hours post-dose: 7 Minutes post CAC | 1.3 Units on a scale | Standard Deviation 2.4 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 16 Hours post-dose: 15 Minutes post CAC | 2.7 Units on a scale | Standard Deviation 3.1 |
| Bepotastine Besilate Ophthalmic Solution 1.0% | Total Nasal Symptom | 8 Hours post-dose: 20 Minutes post CAC | 1.5 Units on a scale | Standard Deviation 2.4 |