Trial Outcomes & Findings for Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers (NCT NCT00586625)
NCT ID: NCT00586625
Last Updated: 2013-02-15
Results Overview
A 4-step grading scale with half unit (1-step) increments allowed: 0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
861 participants
Primary outcome timeframe
Day 8 & Day 22
Results posted on
2013-02-15
Participant Flow
Participant milestones
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
One drop, both eyes, twice a day for six weeks
|
Placebo (Vehicle)
One drop, both eyes, twice a day for six weeks
|
|---|---|---|
|
Overall Study
STARTED
|
575
|
286
|
|
Overall Study
COMPLETED
|
532
|
269
|
|
Overall Study
NOT COMPLETED
|
43
|
17
|
Reasons for withdrawal
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
One drop, both eyes, twice a day for six weeks
|
Placebo (Vehicle)
One drop, both eyes, twice a day for six weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
6
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
32
|
10
|
|
Overall Study
Subject non-compliance
|
0
|
1
|
|
Overall Study
Subject unable to return for visit
|
2
|
0
|
Baseline Characteristics
Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
Baseline characteristics by cohort
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=575 Participants
One drop, both eyes, twice a day for six weeks
|
Placebo (Vehicle)
n=286 Participants
One drop, both eyes, twice a day for six weeks
|
Total
n=861 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
3-9 years
|
47 participants
n=5 Participants
|
25 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Age, Customized
10-17 years
|
40 participants
n=5 Participants
|
15 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Age, Customized
>=18 years
|
488 participants
n=5 Participants
|
246 participants
n=7 Participants
|
734 participants
n=5 Participants
|
|
Age Continuous
|
34.5 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
34.4 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
367 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
545 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
208 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8 & Day 22A 4-step grading scale with half unit (1-step) increments allowed: 0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable
Outcome measures
| Measure |
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
n=575 Participants
One drop, both eyes, twice a day for six weeks
|
Placebo (Vehicle)
n=286 Participants
One drop, both eyes, twice a day for six weeks
|
|---|---|---|
|
Ocular Comfort
Day 8: Upon instillation
|
0.13 Scores on a scale
Standard Deviation 0.35
|
0.07 Scores on a scale
Standard Deviation 0.26
|
|
Ocular Comfort
Day 8: 5 minutes after instillation
|
0.06 Scores on a scale
Standard Deviation 0.25
|
0.02 Scores on a scale
Standard Deviation 0.13
|
|
Ocular Comfort
Day 22: Upon instillation
|
0.1 Scores on a scale
Standard Deviation 0.33
|
0.06 Scores on a scale
Standard Deviation 0.23
|
|
Ocular Comfort
Day 22: 5 minutes after instillation
|
0.05 Scores on a scale
Standard Deviation 0.22
|
0.04 Scores on a scale
Standard Deviation 0.17
|
Adverse Events
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
Serious events: 0 serious events
Other events: 146 other events
Deaths: 0 deaths
Placebo (Vehicle)
Serious events: 0 serious events
Other events: 7 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=575 participants at risk
One drop, both eyes, twice a day for six weeks
|
Placebo (Vehicle)
n=286 participants at risk
One drop, both eyes, twice a day for six weeks
|
|---|---|---|
|
Nervous system disorders
Mild Taste
|
25.4%
146/575
|
2.4%
7/286
|
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