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The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alcaftadine ophthalmic solution | Experimental | active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). |
|
| inactive ophthalmic solution vehicle | Placebo Comparator | Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alcaftadine | Drug | 0.25% Ophthalmic Solution, one drop in each eye at each of two visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. | A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation. | Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge |
| Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation | A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation. | Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment |
| Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation | 0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub" | Visit 4 (Day 14) up to 7 minutes following Allergen Challenge |
| Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation | A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation. | Visit 4 (Day 14) At 20 minutes following Allergen Challenge |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14 | The number of eyes with any change in visual acuity measurements compared to Day -21. | Visit 2 (Day -14) pre-allergen challenge |
| Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairfield | Ohio | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21250860 | Derived | Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011 Mar;27(3):623-31. doi: 10.1185/03007995.2010.548797. Epub 2011 Jan 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcaftadine Ophthalmic Solution | active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14. |
| FG001 | Inactive Vehicle Ophthalmic Solution | inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcaftadine Ophthalmic Solution | active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14. |
| BG001 | Inactive Vehicle Ophthalmic Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. | A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation. | Posted | Mean | Standard Deviation | units on a scale | Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge |
|
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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 | Alcaftadine Ophthalmic Solution | active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Shedden, MD | Johnson & Johnson Vision Care, Inc. | 904-443-1557 | ashedden@its.jnj.com |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| C557708 | alcaftadine |
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| Placebo | Drug | Vehicle without active, one drop in each eye at each of two visits. |
|
The number of eyes with any change in visual acuity measurements compared to Day -21 |
| Visit 3 (Day 0) pre-dose, pre-allergen challenge |
| Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | The number of eyes with any change in visual acuity measurements compared to Day -21 | Visit 4 (Day 14) pre-dose, pre-allergen challenge |
| Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve | Visit 4 (Day 14) pre-dose, pre-allergen challenge |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Visit 2 (Day -14) pre-allergen challenge |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Visit 3 (Day 0) pre-dose, pre-allergen challenge |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Visit 3 (Day 0) post-dose, pre-allergen challenge |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Visit 4 (Day 14) pre-dose, pre-allergen challenge |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Visit 4 (Day 14) post-dose, pre-allergen challenge |
| Mason |
| Ohio |
| United States |
inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
|
|
| Primary | Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation | A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation. | Posted | Mean | Standard Deviation | units on a scale | Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment |
|
|
|
| Primary | Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation | 0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub" | Posted | Mean | Standard Deviation | units on a scale | Visit 4 (Day 14) up to 7 minutes following Allergen Challenge |
|
|
|
| Primary | Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation | A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation. | Posted | Mean | Standard Deviation | units on a scale | Visit 4 (Day 14) At 20 minutes following Allergen Challenge |
|
|
|
| Other Pre-specified | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14 | The number of eyes with any change in visual acuity measurements compared to Day -21. | Posted | Number | eyes | Visit 2 (Day -14) pre-allergen challenge | eyes | Participants |
|
|
|
| Other Pre-specified | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | The number of eyes with any change in visual acuity measurements compared to Day -21 | Posted | Number | eyes | Visit 3 (Day 0) pre-dose, pre-allergen challenge | eyes | Participants |
|
|
|
| Other Pre-specified | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | The number of eyes with any change in visual acuity measurements compared to Day -21 | Posted | Number | eyes | Visit 4 (Day 14) pre-dose, pre-allergen challenge | eyes | Participants |
|
|
|
| Other Pre-specified | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve | Posted | Number | eyes | Visit 4 (Day 14) pre-dose, pre-allergen challenge | eyes | Participants |
|
|
|
| Other Pre-specified | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Posted | Number | eyes | Visit 2 (Day -14) pre-allergen challenge | eyes | Participants |
|
|
|
| Other Pre-specified | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Posted | Number | eyes | Visit 3 (Day 0) pre-dose, pre-allergen challenge | eyes | Participants |
|
|
|
| Other Pre-specified | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Posted | Number | eyes | Visit 3 (Day 0) post-dose, pre-allergen challenge | eyes | Participants |
|
|
|
| Other Pre-specified | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Posted | Number | eyes | Visit 4 (Day 14) pre-dose, pre-allergen challenge | eyes | Participants |
|
|
|
| Other Pre-specified | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus | Posted | Number | eyes | Visit 4 (Day 14) post-dose, pre-allergen challenge | eyes | Participants |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Inactive Vehicle Ophthalmic Solution | inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14. | 0 | 30 | 0 | 30 |
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| Macula |
|
| Choroid |
|
| Optic Nerve |
|
| cornea |
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| iris |
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| lens |
|
| lids |
|
| tear meniscus |
|
| cornea |
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| iris |
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| lens |
|
| lids |
|
| tear meniscus |
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| cornea |
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| iris |
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| lens |
|
| lids |
|
| tear meniscus |
|
| cornea |
|
| iris |
|
| lens |
|
| lids |
|
| tear meniscus |
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| cornea |
|
| iris |
|
| lens |
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| lids |
|
| tear meniscus |
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