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Safety study for bepotastine besilate ophthalmic solution in normal volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bepreve | Experimental | bepotastine besilate ophthalmic solution 1.5% |
|
| Placebo | Placebo Comparator | vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepreve | Drug | One drop, both eyes, twice a day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 8 & Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | One drop, both eyes, twice a day for six weeks |
| FG001 | Placebo (Vehicle) | One drop, both eyes, twice a day for six weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | One drop, both eyes, twice a day for six weeks |
| BG001 | Placebo (Vehicle) | One drop, both eyes, twice a day for six weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | Scores on a scale | Day 8 & Day 22 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | One drop, both eyes, twice a day for six weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Taste | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research & Medical Affairs | ISTA Pharmaceuticals, Inc. | 949-788-6000 | tmcnamara@istavision.com |
Not provided
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| C511534 | bepotastine besilate |
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| Drug |
One drop, both eyes, twice a day |
|
| Withdrawal by Subject |
|
| Subject non-compliance |
|
| Subject unable to return for visit |
|
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 575 |
| 146 |
| 575 |
| EG001 | Placebo (Vehicle) | One drop, both eyes, twice a day for six weeks | 0 | 286 | 7 | 286 |
Agreement is between contract research organization and third parties on behalf of ISTA Pharmaceuticals, Inc.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |