Trial Outcomes & Findings for Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis (NCT NCT00424398)
NCT ID: NCT00424398
Last Updated: 2013-02-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
107 participants
Primary outcome timeframe
15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Results posted on
2013-02-15
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
36
|
|
Overall Study
COMPLETED
|
32
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Subject met exclusion criteria
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<18 years
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
7 participants
n=483 Participants
|
|
Age, Customized
>=18 years
|
33 participants
n=93 Participants
|
34 participants
n=4 Participants
|
33 participants
n=27 Participants
|
100 participants
n=483 Participants
|
|
Age Continuous
|
44.3 years
STANDARD_DEVIATION 16.0 • n=93 Participants
|
40.9 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
39.9 years
STANDARD_DEVIATION 15.2 • n=27 Participants
|
41.7 years
STANDARD_DEVIATION 14.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) ModelOcular 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Ocular Itching
15 Minutes post-dose: 7 Minutes post CAC
|
0.7 Units on a scale
Standard Deviation 0.9
|
2.0 Units on a scale
Standard Deviation 0.7
|
0.7 Units on a scale
Standard Deviation 0.8
|
|
Ocular Itching
15 Minutes post-dose: 3 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.8
|
0.6 Units on a scale
Standard Deviation 0.7
|
|
Ocular Itching
15 Minutes post-dose: 5 Minutes post CAC
|
0.8 Units on a scale
Standard Deviation 0.9
|
2.1 Units on a scale
Standard Deviation 0.8
|
0.7 Units on a scale
Standard Deviation 0.8
|
|
Ocular Itching
8 Hours post-dose: 7 Minutes post CAC
|
0.9 Units on a scale
Standard Deviation 1.0
|
2.2 Units on a scale
Standard Deviation 0.8
|
1.3 Units on a scale
Standard Deviation 0.8
|
|
Ocular Itching
16 Hours post-dose: 5 Minutes post CAC
|
1.5 Units on a scale
Standard Deviation 1.1
|
2.4 Units on a scale
Standard Deviation 0.8
|
1.6 Units on a scale
Standard Deviation 0.9
|
|
Ocular Itching
16 Hours post-dose: 7 Minutes post CAC
|
1.5 Units on a scale
Standard Deviation 1.0
|
2.3 Units on a scale
Standard Deviation 0.8
|
1.4 Units on a scale
Standard Deviation 1.0
|
|
Ocular Itching
8 Hours post-dose: 3 Minutes post CAC
|
0.8 Units on a scale
Standard Deviation 0.9
|
2.0 Units on a scale
Standard Deviation 0.7
|
1.2 Units on a scale
Standard Deviation 0.8
|
|
Ocular Itching
8 Hours post-dose: 5 Minutes post CAC
|
0.9 Units on a scale
Standard Deviation 1.0
|
2.3 Units on a scale
Standard Deviation 0.7
|
1.3 Units on a scale
Standard Deviation 0.8
|
|
Ocular Itching
16 Hours post-dose: 3 Minutes post CAC
|
1.3 Units on a scale
Standard Deviation 1.0
|
2.1 Units on a scale
Standard Deviation 0.9
|
1.4 Units on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) ModelConjunctival 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Conjunctival Redness
15 Minutes post-dose: 7 Minutes post CAC
|
1.4 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.1 Units on a scale
Standard Deviation 0.7
|
|
Conjunctival Redness
8 Hours post-dose: 15 Minutes post CAC
|
1.5 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.6 Units on a scale
Standard Deviation 0.6
|
|
Conjunctival Redness
8 Hours post-dose: 20 Minutes post CAC
|
1.6 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.7
|
1.6 Units on a scale
Standard Deviation 0.7
|
|
Conjunctival Redness
16 Hours post-dose: 20 minutes post CAC
|
1.8 Units on a scale
Standard Deviation 0.6
|
1.7 Units on a scale
Standard Deviation 0.6
|
1.5 Units on a scale
Standard Deviation 0.7
|
|
Conjunctival Redness
15 Minutes post-dose: 15 Minutes post CAC
|
1.7 Units on a scale
Standard Deviation 0.8
|
2.1 Units on a scale
Standard Deviation 0.6
|
1.5 Units on a scale
Standard Deviation 0.7
|
|
Conjunctival Redness
15 Minutes post-dose: 20 Minutes post CAC
|
1.6 Units on a scale
Standard Deviation 0.8
|
2.0 Units on a scale
Standard Deviation 0.6
|
1.4 Units on a scale
Standard Deviation 0.7
|
|
Conjunctival Redness
8 Hours post-dose: 7 Minutes post CAC
|
1.3 Units on a scale
Standard Deviation 0.7
|
1.7 Units on a scale
Standard Deviation 0.7
|
1.3 Units on a scale
Standard Deviation 0.6
|
|
Conjunctival Redness
16 Hours post-dose: 7 Minutes post CAC
|
1.7 Units on a scale
Standard Deviation 0.5
|
1.8 Units on a scale
Standard Deviation 0.6
|
1.4 Units on a scale
Standard Deviation 0.6
|
|
Conjunctival Redness
16 Hours post-dose: 15 Minutes post CAC
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.8 Units on a scale
Standard Deviation 0.6
|
1.5 Units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelCiliary 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Ciliary Redness
15 Minutes post-dose: 15 Minute post CAC
|
1.5 Units on a scale
Standard Deviation 0.9
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.3 Units on a scale
Standard Deviation 0.8
|
|
Ciliary Redness
15 Minutes post-dose: 20 Minute post CAC
|
1.6 Units on a scale
Standard Deviation 0.8
|
1.8 Units on a scale
Standard Deviation 0.7
|
1.3 Units on a scale
Standard Deviation 0.8
|
|
Ciliary Redness
8 Hours post-dose: 7 Minute post CAC
|
1.2 Units on a scale
Standard Deviation 0.8
|
1.5 Units on a scale
Standard Deviation 0.7
|
1.2 Units on a scale
Standard Deviation 0.7
|
|
Ciliary Redness
8 Hours post-dose: 15 Minute post CAC
|
1.5 Units on a scale
Standard Deviation 0.9
|
1.7 Units on a scale
Standard Deviation 0.7
|
1.5 Units on a scale
Standard Deviation 0.7
|
|
Ciliary Redness
8 Hours post-dose: 20 Minute post CAC
|
1.4 Units on a scale
Standard Deviation 0.9
|
1.7 Units on a scale
Standard Deviation 0.7
|
1.4 Units on a scale
Standard Deviation 0.8
|
|
Ciliary Redness
16 Hours post-dose: 20 Minute post CAC
|
1.7 Units on a scale
Standard Deviation 0.7
|
1.8 Units on a scale
Standard Deviation 0.7
|
1.4 Units on a scale
Standard Deviation 0.8
|
|
Ciliary Redness
15 Minutes post-dose: 7 Minute post CAC
|
1.2 Units on a scale
Standard Deviation 0.9
|
1.7 Units on a scale
Standard Deviation 0.6
|
0.9 Units on a scale
Standard Deviation 0.7
|
|
Ciliary Redness
16 Hours post-dose: 7 Minute post CAC
|
1.6 Units on a scale
Standard Deviation 0.7
|
1.7 Units on a scale
Standard Deviation 0.6
|
1.3 Units on a scale
Standard Deviation 0.7
|
|
Ciliary Redness
16 Hours post-dose: 15 Minute post CAC
|
1.9 Units on a scale
Standard Deviation 0.7
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.5 Units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelEpiscleral 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Episcleral Redness
15 Minutes post-dose: 7 Minutes post CAC
|
1.3 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.1 Units on a scale
Standard Deviation 0.7
|
|
Episcleral Redness
15 Minutes post-dose: 15 Minutes post CAC
|
1.6 Units on a scale
Standard Deviation 0.8
|
2.1 Units on a scale
Standard Deviation 0.6
|
1.5 Units on a scale
Standard Deviation 0.7
|
|
Episcleral Redness
15 Minutes post-dose: 20 Minutes post CAC
|
1.6 Units on a scale
Standard Deviation 0.8
|
2.0 Units on a scale
Standard Deviation 0.7
|
1.4 Units on a scale
Standard Deviation 0.7
|
|
Episcleral Redness
8 Hours post-dose: 7 Minutes post CAC
|
1.4 Units on a scale
Standard Deviation 0.7
|
1.7 Units on a scale
Standard Deviation 0.7
|
1.4 Units on a scale
Standard Deviation 0.6
|
|
Episcleral Redness
8 Hours post-dose: 15 Minutes post CAC
|
1.6 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.7 Units on a scale
Standard Deviation 0.6
|
|
Episcleral Redness
8 Hours post-dose: 20 Minutes post CAC
|
1.6 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 0.7
|
1.6 Units on a scale
Standard Deviation 0.7
|
|
Episcleral Redness
16 Hours post-dose: 7 Minutes post CAC
|
1.8 Units on a scale
Standard Deviation 0.5
|
2.0 Units on a scale
Standard Deviation 0.5
|
1.4 Units on a scale
Standard Deviation 0.7
|
|
Episcleral Redness
16 Hours post-dose: 15 Minutes post CAC
|
1.9 Units on a scale
Standard Deviation 0.7
|
2.0 Units on a scale
Standard Deviation 0.5
|
1.6 Units on a scale
Standard Deviation 0.7
|
|
Episcleral Redness
16 Hours post-cose: 20 Minutes post CAC
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.9 Units on a scale
Standard Deviation 0.6
|
1.5 Units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelChemosis 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Chemosis
15 Minutes post-dose: 7 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.3
|
0.7 Units on a scale
Standard Deviation 0.5
|
0.4 Units on a scale
Standard Deviation 0.3
|
|
Chemosis
15 Minutes post-dose: 15 Minutes post CAC
|
0.6 Units on a scale
Standard Deviation 0.5
|
0.9 Units on a scale
Standard Deviation 0.6
|
0.5 Units on a scale
Standard Deviation 0.3
|
|
Chemosis
15 Minutes post-dose: 20 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.3
|
0.8 Units on a scale
Standard Deviation 0.6
|
0.5 Units on a scale
Standard Deviation 0.3
|
|
Chemosis
16 Hours post-dose: 7 Minutes post CAC
|
0.7 Units on a scale
Standard Deviation 0.5
|
0.9 Units on a scale
Standard Deviation 0.4
|
0.6 Units on a scale
Standard Deviation 0.4
|
|
Chemosis
8 Hours post-dose: 7 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.5
|
0.7 Units on a scale
Standard Deviation 0.5
|
0.5 Units on a scale
Standard Deviation 0.4
|
|
Chemosis
8 Hours post-dose: 15 Minutes post CAC
|
0.8 Units on a scale
Standard Deviation 0.7
|
0.9 Units on a scale
Standard Deviation 0.6
|
0.7 Units on a scale
Standard Deviation 0.4
|
|
Chemosis
8 Hours psot-dose: 20 Minutes post CAC
|
0.8 Units on a scale
Standard Deviation 0.7
|
0.9 Units on a scale
Standard Deviation 0.6
|
0.8 Units on a scale
Standard Deviation 0.4
|
|
Chemosis
16 Hours post-dose: 15 Minutes post CAC
|
0.9 Units on a scale
Standard Deviation 0.5
|
1.1 Units on a scale
Standard Deviation 0.5
|
0.8 Units on a scale
Standard Deviation 0.4
|
|
Chemosis
16 Hours post-dose: 20 Minutes post CAC
|
0.9 Units on a scale
Standard Deviation 0.6
|
1.1 Units on a scale
Standard Deviation 0.6
|
0.8 Units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelRhinorrhea 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Rhinorrhea (Runny Nose)
15 Minutes post-dose: 20 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.8
|
0.9 Units on a scale
Standard Deviation 1.1
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
Rhinorrhea (Runny Nose)
8 Hours post-dose: 7 Minutes post CAC
|
0.2 Units on a scale
Standard Deviation 0.5
|
0.9 Units on a scale
Standard Deviation 1.0
|
0.3 Units on a scale
Standard Deviation 0.7
|
|
Rhinorrhea (Runny Nose)
16 Hours post-dose: 7 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.7
|
1.0 Units on a scale
Standard Deviation 1.0
|
0.4 Units on a scale
Standard Deviation 0.8
|
|
Rhinorrhea (Runny Nose)
16 Hours post-dose: 20 Minutes post CAC
|
0.7 Units on a scale
Standard Deviation 0.9
|
1.2 Units on a scale
Standard Deviation 1.2
|
0.8 Units on a scale
Standard Deviation 1.0
|
|
Rhinorrhea (Runny Nose)
15 Minutes post-dose: 7 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.8
|
0.9 Units on a scale
Standard Deviation 1.0
|
0.1 Units on a scale
Standard Deviation 0.3
|
|
Rhinorrhea (Runny Nose)
15 Minutes post-dose: 15 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.9
|
1.1 Units on a scale
Standard Deviation 1.0
|
0.2 Units on a scale
Standard Deviation 0.6
|
|
Rhinorrhea (Runny Nose)
8 Hours post-dose: 15 Minutes post CAC
|
0.3 Units on a scale
Standard Deviation 0.6
|
1.5 Units on a scale
Standard Deviation 1.2
|
0.5 Units on a scale
Standard Deviation 0.8
|
|
Rhinorrhea (Runny Nose)
8 Hours post-dose: 20 Minutes post CAC
|
0.3 Units on a scale
Standard Deviation 0.6
|
1.3 Units on a scale
Standard Deviation 1.3
|
0.4 Units on a scale
Standard Deviation 0.7
|
|
Rhinorrhea (Runny Nose)
16 Hours post-dose: 15 Minutes post CAC
|
0.6 Units on a scale
Standard Deviation 0.8
|
1.4 Units on a scale
Standard Deviation 1.1
|
0.8 Units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelNasal 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Nasal Pruritus (Itchy Nose)
15 Minutes post-dose: 20 Minutes post CAC
|
0.2 Units on a scale
Standard Deviation 0.6
|
0.6 Units on a scale
Standard Deviation 0.8
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
Nasal Pruritus (Itchy Nose)
8 Hours post-dose: 15 Minutes post CAC
|
0.2 Units on a scale
Standard Deviation 0.5
|
0.9 Units on a scale
Standard Deviation 1.1
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
Nasal Pruritus (Itchy Nose)
8 Hours post-dose: 20 Minutes post CAC
|
0.3 Units on a scale
Standard Deviation 0.6
|
0.8 Units on a scale
Standard Deviation 1.1
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
Nasal Pruritus (Itchy Nose)
16 Hours post-dose: 7 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.7
|
0.8 Units on a scale
Standard Deviation 1.0
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
Nasal Pruritus (Itchy Nose)
16 Hours post-dose: 15 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.9
|
0.9 Units on a scale
Standard Deviation 1.1
|
0.4 Units on a scale
Standard Deviation 0.6
|
|
Nasal Pruritus (Itchy Nose)
15 Minutes post-dose: 7 Minutes post CAC
|
0.3 Units on a scale
Standard Deviation 0.7
|
0.7 Units on a scale
Standard Deviation 0.8
|
0.1 Units on a scale
Standard Deviation 0.3
|
|
Nasal Pruritus (Itchy Nose)
15 Minutes post-dose: 15 Minutes post CAC
|
0.2 Units on a scale
Standard Deviation 0.6
|
0.9 Units on a scale
Standard Deviation 0.8
|
0.2 Units on a scale
Standard Deviation 0.5
|
|
Nasal Pruritus (Itchy Nose)
8 Hours post-dose: 7 Minutes post CAC
|
0.1 Units on a scale
Standard Deviation 0.4
|
0.6 Units on a scale
Standard Deviation 0.9
|
0.3 Units on a scale
Standard Deviation 0.7
|
|
Nasal Pruritus (Itchy Nose)
16 Hours post-dose: 20 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.9
|
0.8 Units on a scale
Standard Deviation 1.1
|
0.4 Units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelEar 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
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
|
0.6 Units on a scale
Standard Deviation 0.9
|
0.1 Units on a scale
Standard Deviation 0.2
|
|
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
|
0.9 Units on a scale
Standard Deviation 1.0
|
0.2 Units on a scale
Standard Deviation 0.5
|
|
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
|
0.9 Units on a scale
Standard Deviation 1.0
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
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
|
0.6 Units on a scale
Standard Deviation 0.9
|
0.4 Units on a scale
Standard Deviation 0.8
|
|
Ear or Palate Pruritus (Itchy Ear or Palate)
16 Hours post-dose: 15 Minutes post CAC
|
0.8 Units on a scale
Standard Deviation 1.0
|
1.0 Units on a scale
Standard Deviation 1.2
|
0.8 Units on a scale
Standard Deviation 1.2
|
|
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
|
1.2 Units on a scale
Standard Deviation 1.2
|
0.4 Units on a scale
Standard Deviation 0.8
|
|
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
|
0.9 Units on a scale
Standard Deviation 1.1
|
0.5 Units on a scale
Standard Deviation 0.9
|
|
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
|
0.6 Units on a scale
Standard Deviation 0.9
|
0.3 Units on a scale
Standard Deviation 0.8
|
|
Ear or Palate Pruritus (Itchy Ear or Palate)
16 Hours post-dose: 20 Minutes post CAC
|
0.8 Units on a scale
Standard Deviation 1.0
|
0.9 Units on a scale
Standard Deviation 1.2
|
0.8 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) ModelNasal 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Nasal Congestion
15 Minutes post-dose: 7 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 1.0
|
0.9 Units on a scale
Standard Deviation 1.0
|
0.2 Units on a scale
Standard Deviation 0.4
|
|
Nasal Congestion
15 Minutes post-dose: 15 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.9
|
1.1 Units on a scale
Standard Deviation 1.2
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
Nasal Congestion
8 Hours post-dose: 15 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.8
|
1.2 Units on a scale
Standard Deviation 1.2
|
0.4 Units on a scale
Standard Deviation 0.7
|
|
Nasal Congestion
16 Hours post-dose: 7 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.7
|
1.0 Units on a scale
Standard Deviation 1.0
|
0.4 Units on a scale
Standard Deviation 0.8
|
|
Nasal Congestion
16 Hours post-dose: 15 Minutes post CAC
|
0.7 Units on a scale
Standard Deviation 1.0
|
1.3 Units on a scale
Standard Deviation 1.1
|
0.8 Units on a scale
Standard Deviation 1.0
|
|
Nasal Congestion
15 Minutes post-dose: 20 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.9
|
1.2 Units on a scale
Standard Deviation 1.1
|
0.3 Units on a scale
Standard Deviation 0.5
|
|
Nasal Congestion
8 Hours post-dose: 7 Minutes post CAC
|
0.2 Units on a scale
Standard Deviation 0.5
|
0.9 Units on a scale
Standard Deviation 1.0
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
Nasal Congestion
8 Hours post-dose: 20 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.8
|
1.1 Units on a scale
Standard Deviation 1.2
|
0.4 Units on a scale
Standard Deviation 0.7
|
|
Nasal Congestion
16 Hours post-dose: 20 Minutes post CAC
|
0.7 Units on a scale
Standard Deviation 1.0
|
1.2 Units on a scale
Standard Deviation 1.2
|
0.8 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelPercent of Eyes with Tearing. Scored as absent or present
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Tearing
8 Hours post-dose: 20 Minutes post CAC
|
12.9 Percent of Eyes with Tearing Present
|
40.3 Percent of Eyes with Tearing Present
|
15.3 Percent of Eyes with Tearing Present
|
|
Tearing
16 Hours post-dose: 15 Minutes post CAC
|
15.7 Percent of Eyes with Tearing Present
|
44.4 Percent of Eyes with Tearing Present
|
19.4 Percent of Eyes with Tearing Present
|
|
Tearing
15 Minutes post-dose: 7 Minutes post CAC
|
14.3 Percent of Eyes with Tearing Present
|
43.1 Percent of Eyes with Tearing Present
|
6.9 Percent of Eyes with Tearing Present
|
|
Tearing
15 Minutes post-dose: 15 Minutes post CAC
|
17.1 Percent of Eyes with Tearing Present
|
34.7 Percent of Eyes with Tearing Present
|
9.7 Percent of Eyes with Tearing Present
|
|
Tearing
15 Minutes post-dose: 20 Minutes post CAC
|
17.1 Percent of Eyes with Tearing Present
|
38.9 Percent of Eyes with Tearing Present
|
11.1 Percent of Eyes with Tearing Present
|
|
Tearing
8 Hours post-dose: 7 Minutes post CAC
|
12.9 Percent of Eyes with Tearing Present
|
50.0 Percent of Eyes with Tearing Present
|
13.9 Percent of Eyes with Tearing Present
|
|
Tearing
8 Hours post-dose: 15 Minutes post CAC
|
14.3 Percent of Eyes with Tearing Present
|
56.9 Percent of Eyes with Tearing Present
|
16.7 Percent of Eyes with Tearing Present
|
|
Tearing
16 Hours post-dose: 7 Minutes post CAC
|
11.4 Percent of Eyes with Tearing Present
|
43.1 Percent of Eyes with Tearing Present
|
23.6 Percent of Eyes with Tearing Present
|
|
Tearing
16 Hours post-dose: 20 Minutes post CAC
|
15.7 Percent of Eyes with Tearing Present
|
34.7 Percent of Eyes with Tearing Present
|
23.6 Percent of Eyes with Tearing Present
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelPercent of Eyes with Ocular Mucus Discharge. Scored as absent or present
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Ocular Mucus Discharge
15 Minutes post-dose: 7 Minutes post CAC
|
0.0 Percent of Eyes with OMD Present
|
1.4 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
|
Ocular Mucus Discharge
15 Minutes post-dose: 15 Minutes post CAC
|
2.9 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
|
Ocular Mucus Discharge
15 Minutes post-dose: 20 Minutes post CAC
|
2.9 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
|
Ocular Mucus Discharge
8 Hours post-dose: 7 Minutes post CAC
|
0.0 Percent of Eyes with OMD Present
|
1.4 Percent of Eyes with OMD Present
|
1.4 Percent of Eyes with OMD Present
|
|
Ocular Mucus Discharge
8 Hours post-dose: 15 Minutes post CAC
|
0.0 Percent of Eyes with OMD Present
|
2.8 Percent of Eyes with OMD Present
|
1.4 Percent of Eyes with OMD Present
|
|
Ocular Mucus Discharge
8 Hours post-dose: 20 Minutes post CAC
|
0.0 Percent of Eyes with OMD Present
|
2.8 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
|
Ocular Mucus Discharge
16 Hours post-dose: 7 Minutes post CAC
|
0.0 Percent of Eyes with OMD Present
|
2.8 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
|
Ocular Mucus Discharge
16 Hours post-dose: 15 Minutes post CAC
|
0.0 Percent of Eyes with OMD Present
|
5.6 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
|
Ocular Mucus Discharge
16 Hours post-dose: 20 Minutes post CAC
|
0.0 Percent of Eyes with OMD Present
|
5.6 Percent of Eyes with OMD Present
|
0.0 Percent of Eyes with OMD Present
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelEyelid 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Eyelid Swelling
8 Hours post-dose: 15 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.8
|
0.9 Units on a scale
Standard Deviation 0.9
|
0.4 Units on a scale
Standard Deviation 0.6
|
|
Eyelid Swelling
8 Hours post-dose: 20 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.7
|
0.9 Units on a scale
Standard Deviation 0.9
|
0.4 Units on a scale
Standard Deviation 0.6
|
|
Eyelid Swelling
15 Minutes post-dose: 7 Minutes post CAC
|
0.3 Units on a scale
Standard Deviation 0.5
|
0.7 Units on a scale
Standard Deviation 0.7
|
0.2 Units on a scale
Standard Deviation 0.5
|
|
Eyelid Swelling
16 Hours post-dose: 15 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.7
|
0.9 Units on a scale
Standard Deviation 0.9
|
0.4 Units on a scale
Standard Deviation 0.6
|
|
Eyelid Swelling
15 Minutes post-dose: 15 Minutes post CAC
|
0.3 Units on a scale
Standard Deviation 0.5
|
0.8 Units on a scale
Standard Deviation 0.7
|
0.2 Units on a scale
Standard Deviation 0.6
|
|
Eyelid Swelling
15 Minutes post-dose: 20 Minutes post CAC
|
0.3 Units on a scale
Standard Deviation 0.5
|
0.9 Units on a scale
Standard Deviation 0.7
|
0.3 Units on a scale
Standard Deviation 0.6
|
|
Eyelid Swelling
8 Hours post-dose: 7 Minutes post CAC
|
0.4 Units on a scale
Standard Deviation 0.7
|
0.7 Units on a scale
Standard Deviation 0.7
|
0.3 Units on a scale
Standard Deviation 0.5
|
|
Eyelid Swelling
16 Hours post-dose: 7 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.6
|
0.7 Units on a scale
Standard Deviation 0.7
|
0.3 Units on a scale
Standard Deviation 0.5
|
|
Eyelid Swelling
16 Hours post-dose: 20 Minutes post CAC
|
0.5 Units on a scale
Standard Deviation 0.7
|
0.8 Units on a scale
Standard Deviation 0.8
|
0.5 Units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) ModelTotal 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
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 Participants
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
|
Placebo
n=36 Participants
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 Participants
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
|
|---|---|---|---|
|
Total Nasal Symptom
15 Minutes post-dose: 15 Minutes post CAC
|
1.7 Units on a scale
Standard Deviation 2.2
|
4.0 Units on a scale
Standard Deviation 3.4
|
0.9 Units on a scale
Standard Deviation 1.5
|
|
Total Nasal Symptom
15 Minutes post-dose: 20 Minutes post CAC
|
1.6 Units on a scale
Standard Deviation 2.2
|
3.6 Units on a scale
Standard Deviation 3.2
|
1.0 Units on a scale
Standard Deviation 1.6
|
|
Total Nasal Symptom
8 Hours post-dose: 15 Minutes post CAC
|
1.3 Units on a scale
Standard Deviation 2.2
|
4.8 Units on a scale
Standard Deviation 4.0
|
1.6 Units on a scale
Standard Deviation 2.5
|
|
Total Nasal Symptom
8 Hours post-dose: 20 Minutes post CAC
|
1.5 Units on a scale
Standard Deviation 2.4
|
4.0 Units on a scale
Standard Deviation 4.0
|
1.5 Units on a scale
Standard Deviation 2.4
|
|
Total Nasal Symptom
16 Hours post-dose: 7 Minutes post CAC
|
1.8 Units on a scale
Standard Deviation 2.0
|
3.4 Units on a scale
Standard Deviation 3.2
|
1.3 Units on a scale
Standard Deviation 2.6
|
|
Total Nasal Symptom
15 Minutes post-dose: 7 Minutes post CAC
|
1.3 Units on a scale
Standard Deviation 2.2
|
3.2 Units on a scale
Standard Deviation 3.1
|
0.4 Units on a scale
Standard Deviation 0.8
|
|
Total Nasal Symptom
8 Hours post-dose: 7 Minutes post CAC
|
0.7 Units on a scale
Standard Deviation 1.6
|
2.9 Units on a scale
Standard Deviation 3.1
|
1.3 Units on a scale
Standard Deviation 2.4
|
|
Total Nasal Symptom
16 Hours post-dose: 15 Minutes post CAC
|
2.5 Units on a scale
Standard Deviation 2.9
|
4.5 Units on a scale
Standard Deviation 4.0
|
2.7 Units on a scale
Standard Deviation 3.1
|
|
Total Nasal Symptom
16 Hours post-dose: 20 Minutes post CAC
|
2.6 Units on a scale
Standard Deviation 3.1
|
4.0 Units on a scale
Standard Deviation 4.3
|
2.8 Units on a scale
Standard Deviation 3.3
|
Adverse Events
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Bepotastine Besilate Ophthalmic Solution 1.0%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=35 participants at risk
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
|
Placebo
n=36 participants at risk
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
|
Bepotastine Besilate Ophthalmic Solution 1.0%
n=36 participants at risk
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
|
|---|---|---|---|
|
Nervous system disorders
Mild Taste
|
8.6%
3/35
|
0.00%
0/36
|
16.7%
6/36
|
|
Eye disorders
Eye Irritation
|
2.9%
1/35
|
5.6%
2/36
|
0.00%
0/36
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/35
|
0.00%
0/36
|
5.6%
2/36
|
Additional Information
Vice President, Clinical Research & Medical Affairs
ISTA Pharmaceuticals, Inc.
Phone: 949-788-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement is between contract research organization and third parties on behalf of ISTA Pharmaceuticals, Inc.
- Publication restrictions are in place
Restriction type: OTHER