Allergic Conjunctivitis
Conditions
Brief summary
Safety study for bepotastine besilate ophthalmic solution in normal volunteers
Interventions
DRUGBepreve
One drop, both eyes, twice a day
DRUGPlacebo
One drop, both eyes, twice a day
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be at least 3 years of age, and have ocular health within normal limits
Exclusion criteria
* No active ocular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Comfort | Day 8 & Day 22 | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% One drop, both eyes, twice a day for six weeks | 575 |
| Placebo (Vehicle) One drop, both eyes, twice a day for six weeks | 286 |
| Total | 861 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Subject non-compliance | 0 | 1 |
| Overall Study | Subject unable to return for visit | 2 | 0 |
| Overall Study | Withdrawal by Subject | 32 | 10 |
Baseline characteristics
| Characteristic | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Placebo (Vehicle) | Total |
|---|---|---|---|
| Age Continuous | 34.5 years STANDARD_DEVIATION 16.5 | 34.2 years STANDARD_DEVIATION 16.3 | 34.4 years STANDARD_DEVIATION 16.4 |
| Age, Customized 10-17 years | 40 participants | 15 participants | 55 participants |
| Age, Customized >=18 years | 488 participants | 246 participants | 734 participants |
| Age, Customized 3-9 years | 47 participants | 25 participants | 72 participants |
| Sex: Female, Male Female | 367 Participants | 178 Participants | 545 Participants |
| Sex: Female, Male Male | 208 Participants | 108 Participants | 316 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 146 / 575 | 7 / 286 |
| serious Total, serious adverse events | 0 / 575 | 0 / 286 |
Outcome results
Primary
Ocular Comfort
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
Time frame: Day 8 & Day 22
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Comfort | Day 8: Upon instillation | 0.13 Scores on a scale | Standard Deviation 0.35 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Comfort | Day 8: 5 minutes after instillation | 0.06 Scores on a scale | Standard Deviation 0.25 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Comfort | Day 22: Upon instillation | 0.1 Scores on a scale | Standard Deviation 0.33 |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | Ocular Comfort | Day 22: 5 minutes after instillation | 0.05 Scores on a scale | Standard Deviation 0.22 |
| Placebo (Vehicle) | Ocular Comfort | Day 22: 5 minutes after instillation | 0.04 Scores on a scale | Standard Deviation 0.17 |
| Placebo (Vehicle) | Ocular Comfort | Day 8: Upon instillation | 0.07 Scores on a scale | Standard Deviation 0.26 |
| Placebo (Vehicle) | Ocular Comfort | Day 22: Upon instillation | 0.06 Scores on a scale | Standard Deviation 0.23 |
| Placebo (Vehicle) | Ocular Comfort | Day 8: 5 minutes after instillation | 0.02 Scores on a scale | Standard Deviation 0.13 |