Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00424398
Collaborator
(none)
107
1
3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis
Study Start Date
:
Feb 1, 2007
Actual Primary Completion Date
:
Jul 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bepreve Bepotastine Besilate Ophthalmic Solution 1.5% |
Drug: Bepreve
sterile ophthalmic solution
|
| Placebo Comparator: Placebo sterile ophthalmic solution |
Drug: Placebo
sterile ophthalmic solution
|
| Experimental: Bepotastine Besilate sterile ophthalmic solution 1.0% |
Drug: Bepotastine Besilate
sterile ophthalmic solution
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ISTA Pharmaceuticals, Inc. | Irvine | California | United States | 92630 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Jon Williams, PhD, ISTA Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00424398
Other Study ID Numbers:
- ISTA-BEPO-CS01
First Posted:
Jan 19, 2007
Last Update Posted:
Feb 15, 2013
Last Verified:
Feb 1, 2013
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Period Title: Overall Study | |||
| STARTED | 35 | 36 | 36 |
| COMPLETED | 32 | 35 | 36 |
| NOT COMPLETED | 3 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 of all reporting groups |
| Overall Participants | 35 | 36 | 36 | 107 |
| Age, Customized (participants) [Number] | ||||
| <18 years |
2
5.7%
|
2
5.6%
|
3
8.3%
|
7
6.5%
|
| >=18 years |
33
94.3%
|
34
94.4%
|
33
91.7%
|
100
93.5%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
44.3
(16.0)
|
40.9
(11.4)
|
39.9
(15.2)
|
41.7
(14.3)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
18
51.4%
|
17
47.2%
|
14
38.9%
|
49
45.8%
|
| Male |
17
48.6%
|
19
52.8%
|
22
61.1%
|
58
54.2%
|
Outcome Measures
| Title | Ocular Itching |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 3 Minutes post CAC |
0.5
(0.8)
|
1.9
(0.8)
|
0.6
(0.7)
|
| 15 Minutes post-dose: 5 Minutes post CAC |
0.8
(0.9)
|
2.1
(0.8)
|
0.7
(0.8)
|
| 15 Minutes post-dose: 7 Minutes post CAC |
0.7
(0.9)
|
2.0
(0.7)
|
0.7
(0.8)
|
| 8 Hours post-dose: 3 Minutes post CAC |
0.8
(0.9)
|
2.0
(0.7)
|
1.2
(0.8)
|
| 8 Hours post-dose: 5 Minutes post CAC |
0.9
(1.0)
|
2.3
(0.7)
|
1.3
(0.8)
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.9
(1.0)
|
2.2
(0.8)
|
1.3
(0.8)
|
| 16 Hours post-dose: 3 Minutes post CAC |
1.3
(1.0)
|
2.1
(0.9)
|
1.4
(0.7)
|
| 16 Hours post-dose: 5 Minutes post CAC |
1.5
(1.1)
|
2.4
(0.8)
|
1.6
(0.9)
|
| 16 Hours post-dose: 7 Minutes post CAC |
1.5
(1.0)
|
2.3
(0.8)
|
1.4
(1.0)
|
| Title | Conjunctival Redness |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
1.4
(0.8)
|
1.9
(0.6)
|
1.1
(0.7)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
1.7
(0.8)
|
2.1
(0.6)
|
1.5
(0.7)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
1.6
(0.8)
|
2.0
(0.6)
|
1.4
(0.7)
|
| 8 Hours post-dose: 7 Minutes post CAC |
1.3
(0.7)
|
1.7
(0.7)
|
1.3
(0.6)
|
| 8 Hours post-dose: 15 Minutes post CAC |
1.5
(0.8)
|
1.9
(0.6)
|
1.6
(0.6)
|
| 8 Hours post-dose: 20 Minutes post CAC |
1.6
(0.8)
|
1.9
(0.7)
|
1.6
(0.7)
|
| 16 Hours post-dose: 7 Minutes post CAC |
1.7
(0.5)
|
1.8
(0.6)
|
1.4
(0.6)
|
| 16 Hours post-dose: 15 Minutes post CAC |
1.9
(0.6)
|
1.8
(0.6)
|
1.5
(0.7)
|
| 16 Hours post-dose: 20 minutes post CAC |
1.8
(0.6)
|
1.7
(0.6)
|
1.5
(0.7)
|
| Title | Ciliary Redness |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minute post CAC |
1.2
(0.9)
|
1.7
(0.6)
|
0.9
(0.7)
|
| 15 Minutes post-dose: 15 Minute post CAC |
1.5
(0.9)
|
1.9
(0.6)
|
1.3
(0.8)
|
| 15 Minutes post-dose: 20 Minute post CAC |
1.6
(0.8)
|
1.8
(0.7)
|
1.3
(0.8)
|
| 8 Hours post-dose: 7 Minute post CAC |
1.2
(0.8)
|
1.5
(0.7)
|
1.2
(0.7)
|
| 8 Hours post-dose: 15 Minute post CAC |
1.5
(0.9)
|
1.7
(0.7)
|
1.5
(0.7)
|
| 8 Hours post-dose: 20 Minute post CAC |
1.4
(0.9)
|
1.7
(0.7)
|
1.4
(0.8)
|
| 16 Hours post-dose: 7 Minute post CAC |
1.6
(0.7)
|
1.7
(0.6)
|
1.3
(0.7)
|
| 16 Hours post-dose: 15 Minute post CAC |
1.9
(0.7)
|
1.9
(0.6)
|
1.5
(0.7)
|
| 16 Hours post-dose: 20 Minute post CAC |
1.7
(0.7)
|
1.8
(0.7)
|
1.4
(0.8)
|
| Title | Episcleral Redness |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
1.3
(0.8)
|
1.9
(0.6)
|
1.1
(0.7)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
1.6
(0.8)
|
2.1
(0.6)
|
1.5
(0.7)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
1.6
(0.8)
|
2.0
(0.7)
|
1.4
(0.7)
|
| 8 Hours post-dose: 7 Minutes post CAC |
1.4
(0.7)
|
1.7
(0.7)
|
1.4
(0.6)
|
| 8 Hours post-dose: 15 Minutes post CAC |
1.6
(0.8)
|
1.9
(0.6)
|
1.7
(0.6)
|
| 8 Hours post-dose: 20 Minutes post CAC |
1.6
(0.8)
|
1.9
(0.7)
|
1.6
(0.7)
|
| 16 Hours post-dose: 7 Minutes post CAC |
1.8
(0.5)
|
2.0
(0.5)
|
1.4
(0.7)
|
| 16 Hours post-dose: 15 Minutes post CAC |
1.9
(0.7)
|
2.0
(0.5)
|
1.6
(0.7)
|
| 16 Hours post-cose: 20 Minutes post CAC |
1.9
(0.6)
|
1.9
(0.6)
|
1.5
(0.8)
|
| Title | Chemosis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
0.4
(0.3)
|
0.7
(0.5)
|
0.4
(0.3)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
0.6
(0.5)
|
0.9
(0.6)
|
0.5
(0.3)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
0.5
(0.3)
|
0.8
(0.6)
|
0.5
(0.3)
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.5
(0.5)
|
0.7
(0.5)
|
0.5
(0.4)
|
| 8 Hours post-dose: 15 Minutes post CAC |
0.8
(0.7)
|
0.9
(0.6)
|
0.7
(0.4)
|
| 8 Hours psot-dose: 20 Minutes post CAC |
0.8
(0.7)
|
0.9
(0.6)
|
0.8
(0.4)
|
| 16 Hours post-dose: 7 Minutes post CAC |
0.7
(0.5)
|
0.9
(0.4)
|
0.6
(0.4)
|
| 16 Hours post-dose: 15 Minutes post CAC |
0.9
(0.5)
|
1.1
(0.5)
|
0.8
(0.4)
|
| 16 Hours post-dose: 20 Minutes post CAC |
0.9
(0.6)
|
1.1
(0.6)
|
0.8
(0.5)
|
| Title | Rhinorrhea (Runny Nose) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
0.4
(0.8)
|
0.9
(1.0)
|
0.1
(0.3)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
0.5
(0.9)
|
1.1
(1.0)
|
0.2
(0.6)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
0.4
(0.8)
|
0.9
(1.1)
|
0.3
(0.6)
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.2
(0.5)
|
0.9
(1.0)
|
0.3
(0.7)
|
| 8 Hours post-dose: 15 Minutes post CAC |
0.3
(0.6)
|
1.5
(1.2)
|
0.5
(0.8)
|
| 8 Hours post-dose: 20 Minutes post CAC |
0.3
(0.6)
|
1.3
(1.3)
|
0.4
(0.7)
|
| 16 Hours post-dose: 7 Minutes post CAC |
0.4
(0.7)
|
1.0
(1.0)
|
0.4
(0.8)
|
| 16 Hours post-dose: 15 Minutes post CAC |
0.6
(0.8)
|
1.4
(1.1)
|
0.8
(0.9)
|
| 16 Hours post-dose: 20 Minutes post CAC |
0.7
(0.9)
|
1.2
(1.2)
|
0.8
(1.0)
|
| Title | Nasal Pruritus (Itchy Nose) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
0.3
(0.7)
|
0.7
(0.8)
|
0.1
(0.3)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
0.2
(0.6)
|
0.9
(0.8)
|
0.2
(0.5)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
0.2
(0.6)
|
0.6
(0.8)
|
0.3
(0.6)
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.1
(0.4)
|
0.6
(0.9)
|
0.3
(0.7)
|
| 8 Hours post-dose: 15 Minutes post CAC |
0.2
(0.5)
|
0.9
(1.1)
|
0.3
(0.6)
|
| 8 Hours post-dose: 20 Minutes post CAC |
0.3
(0.6)
|
0.8
(1.1)
|
0.3
(0.6)
|
| 16 Hours post-dose: 7 Minutes post CAC |
0.5
(0.7)
|
0.8
(1.0)
|
0.3
(0.6)
|
| 16 Hours post-dose: 15 Minutes post CAC |
0.5
(0.9)
|
0.9
(1.1)
|
0.4
(0.6)
|
| 16 Hours post-dose: 20 Minutes post CAC |
0.5
(0.9)
|
0.8
(1.1)
|
0.4
(0.7)
|
| Title | Ear or Palate Pruritus (Itchy Ear or Palate) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
0.3
(0.7)
|
0.6
(0.9)
|
0.1
(0.2)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
0.6
(0.9)
|
0.9
(1.0)
|
0.2
(0.5)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
0.6
(0.9)
|
0.9
(1.0)
|
0.3
(0.6)
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.2
(0.5)
|
0.6
(0.9)
|
0.4
(0.8)
|
| 8 Hours post-dose: 15 Minutes post CAC |
0.4
(0.9)
|
1.2
(1.2)
|
0.4
(0.8)
|
| 8 Hours post-dose: 20 Minutes post CAC |
0.5
(0.8)
|
0.9
(1.1)
|
0.5
(0.9)
|
| 16 Hours post-dose: 7 Minutes post CAC |
0.5
(0.7)
|
0.6
(0.9)
|
0.3
(0.8)
|
| 16 Hours post-dose: 15 Minutes post CAC |
0.8
(1.0)
|
1.0
(1.2)
|
0.8
(1.2)
|
| 16 Hours post-dose: 20 Minutes post CAC |
0.8
(1.0)
|
0.9
(1.2)
|
0.8
(1.1)
|
| Title | Nasal Congestion |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
0.5
(1.0)
|
0.9
(1.0)
|
0.2
(0.4)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
0.4
(0.9)
|
1.1
(1.2)
|
0.3
(0.6)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
0.4
(0.9)
|
1.2
(1.1)
|
0.3
(0.5)
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.2
(0.5)
|
0.9
(1.0)
|
0.3
(0.6)
|
| 8 Hours post-dose: 15 Minutes post CAC |
0.4
(0.8)
|
1.2
(1.2)
|
0.4
(0.7)
|
| 8 Hours post-dose: 20 Minutes post CAC |
0.4
(0.8)
|
1.1
(1.2)
|
0.4
(0.7)
|
| 16 Hours post-dose: 7 Minutes post CAC |
0.4
(0.7)
|
1.0
(1.0)
|
0.4
(0.8)
|
| 16 Hours post-dose: 15 Minutes post CAC |
0.7
(1.0)
|
1.3
(1.1)
|
0.8
(1.0)
|
| 16 Hours post-dose: 20 Minutes post CAC |
0.7
(1.0)
|
1.2
(1.2)
|
0.8
(1.0)
|
| Title | Tearing |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
14.3
|
43.1
|
6.9
|
| 15 Minutes post-dose: 15 Minutes post CAC |
17.1
|
34.7
|
9.7
|
| 15 Minutes post-dose: 20 Minutes post CAC |
17.1
|
38.9
|
11.1
|
| 8 Hours post-dose: 7 Minutes post CAC |
12.9
|
50.0
|
13.9
|
| 8 Hours post-dose: 15 Minutes post CAC |
14.3
|
56.9
|
16.7
|
| 8 Hours post-dose: 20 Minutes post CAC |
12.9
|
40.3
|
15.3
|
| 16 Hours post-dose: 7 Minutes post CAC |
11.4
|
43.1
|
23.6
|
| 16 Hours post-dose: 15 Minutes post CAC |
15.7
|
44.4
|
19.4
|
| 16 Hours post-dose: 20 Minutes post CAC |
15.7
|
34.7
|
23.6
|
| Title | Ocular Mucus Discharge |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
0.0
|
1.4
|
0.0
|
| 15 Minutes post-dose: 15 Minutes post CAC |
2.9
|
0.0
|
0.0
|
| 15 Minutes post-dose: 20 Minutes post CAC |
2.9
|
0.0
|
0.0
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.0
|
1.4
|
1.4
|
| 8 Hours post-dose: 15 Minutes post CAC |
0.0
|
2.8
|
1.4
|
| 8 Hours post-dose: 20 Minutes post CAC |
0.0
|
2.8
|
0.0
|
| 16 Hours post-dose: 7 Minutes post CAC |
0.0
|
2.8
|
0.0
|
| 16 Hours post-dose: 15 Minutes post CAC |
0.0
|
5.6
|
0.0
|
| 16 Hours post-dose: 20 Minutes post CAC |
0.0
|
5.6
|
0.0
|
| Title | Eyelid Swelling |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
0.3
(0.5)
|
0.7
(0.7)
|
0.2
(0.5)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
0.3
(0.5)
|
0.8
(0.7)
|
0.2
(0.6)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
0.3
(0.5)
|
0.9
(0.7)
|
0.3
(0.6)
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.4
(0.7)
|
0.7
(0.7)
|
0.3
(0.5)
|
| 8 Hours post-dose: 15 Minutes post CAC |
0.5
(0.8)
|
0.9
(0.9)
|
0.4
(0.6)
|
| 8 Hours post-dose: 20 Minutes post CAC |
0.5
(0.7)
|
0.9
(0.9)
|
0.4
(0.6)
|
| 16 Hours post-dose: 7 Minutes post CAC |
0.5
(0.6)
|
0.7
(0.7)
|
0.3
(0.5)
|
| 16 Hours post-dose: 15 Minutes post CAC |
0.5
(0.7)
|
0.9
(0.9)
|
0.4
(0.6)
|
| 16 Hours post-dose: 20 Minutes post CAC |
0.5
(0.7)
|
0.8
(0.8)
|
0.5
(0.6)
|
| Title | Total Nasal Symptom |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 35 | 36 | 36 |
| 15 Minutes post-dose: 7 Minutes post CAC |
1.3
(2.2)
|
3.2
(3.1)
|
0.4
(0.8)
|
| 15 Minutes post-dose: 15 Minutes post CAC |
1.7
(2.2)
|
4.0
(3.4)
|
0.9
(1.5)
|
| 15 Minutes post-dose: 20 Minutes post CAC |
1.6
(2.2)
|
3.6
(3.2)
|
1.0
(1.6)
|
| 8 Hours post-dose: 7 Minutes post CAC |
0.7
(1.6)
|
2.9
(3.1)
|
1.3
(2.4)
|
| 8 Hours post-dose: 15 Minutes post CAC |
1.3
(2.2)
|
4.8
(4.0)
|
1.6
(2.5)
|
| 8 Hours post-dose: 20 Minutes post CAC |
1.5
(2.4)
|
4.0
(4.0)
|
1.5
(2.4)
|
| 16 Hours post-dose: 7 Minutes post CAC |
1.8
(2.0)
|
3.4
(3.2)
|
1.3
(2.6)
|
| 16 Hours post-dose: 15 Minutes post CAC |
2.5
(2.9)
|
4.5
(4.0)
|
2.7
(3.1)
|
| 16 Hours post-dose: 20 Minutes post CAC |
2.6
(3.1)
|
4.0
(4.3)
|
2.8
(3.3)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% | |||
| Arm/Group Description | 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 | 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 | 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 | |||
All Cause Mortality |
||||||
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/35 (0%) | 0/36 (0%) | 0/36 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo | Bepotastine Besilate Ophthalmic Solution 1.0% | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/35 (11.4%) | 2/36 (5.6%) | 8/36 (22.2%) | |||
| Eye disorders | ||||||
| Eye Irritation | 1/35 (2.9%) | 2/36 (5.6%) | 0/36 (0%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 0/35 (0%) | 0/36 (0%) | 2/36 (5.6%) | |||
| Nervous system disorders | ||||||
| Mild Taste | 3/35 (8.6%) | 0/36 (0%) | 6/36 (16.7%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Agreement is between contract research organization and third parties on behalf of ISTA Pharmaceuticals, Inc.
Results Point of Contact
| Name/Title | Vice President, Clinical Research & Medical Affairs |
|---|---|
| Organization | ISTA Pharmaceuticals, Inc. |
| Phone | 949-788-6000 |
| tmcnamara@istavision.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00424398
Other Study ID Numbers:
- ISTA-BEPO-CS01
First Posted:
Jan 19, 2007
Last Update Posted:
Feb 15, 2013
Last Verified:
Feb 1, 2013