| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| | | Title | Denominators | Categories |
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| 15 Minutes post-dose: 3 minute post CAC | | | Title | Measurements |
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| - OG0000.4± 0.6
- OG0011.9± 1.0
- OG0020.4± 0.7
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| | 15 Minutes post-dose: 5 minute post CAC |
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| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
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| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
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| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
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| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | Total Non-Ocular Composite Symptom | Total Non-Ocular Composite 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 | | Posted | | Mean | Standard Deviation | Units on a scale | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
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| Secondary | Tearing | Percent of Eyes with Tearing as measured 7, 15 & 20 minutes post-CAC. Scored as absent or present | | Posted | | Number | | Percent of Eyes with Tearing Present | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | Ocular Mucus Discharge | Percent of Eyes with Ocular Mucus Discharge as measured 7, 15 & 20 minutes post-CAC. Scored as absent or present | | Posted | | Number | | Percent of Eyes with OMD Present | | 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
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