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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000013943 | Registry Identifier | UMIN |
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The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine (right or left, randomized) | Experimental | Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized |
|
| Epinastine (fellow eye) | Active Comparator | Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine HCl ophthalmic solution, 0.1% | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 | A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub). | Day 1, 7 minutes post-CAC |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1 | A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe). | Day 1, 20 minutes post-CAC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsunemitsu Senta | Alcon Japan, Ltd. | Study Director |
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All subjects qualifying for treatment at Visit 3 were randomized. This reporting group includes all randomized participants (50).
Participants were recruited from 1 study site located in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This reporting group includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized |
| 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 | Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 | A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub). | This analysis population includes all randomized participants. | Posted | Mean | Standard Deviation | units on a scale | Day 1, 7 minutes post-CAC | eyes | Participants |
|
Adverse events (AEs) were collected for the duration of the study (December, 2013 - January, 2014). This analysis group includes all randomized subjects who received at least 1 dose of study medication.
An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment, except for skin test and allergic symptom caused by CAC. AEs were obtained through solicited and spontaneous comments from the subjects.
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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 | Olopatadine 0.1% | Ophthalmic solution, 1 drop instilled in 1 eye, as randomized. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hironari Sakaguchi, Phase IV Clinical & Regulatory Affairs, Japan | Alcon Japan, Ltd. | +81 3 6899 5054 | Hironari.Sakaguchi@alcon.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 |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Epinastine HCl ophthalmic solution, 0.05% |
| Drug |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1 | A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe). | This analysis population includes all randomized participants. | Posted | Mean | Standard Deviation | units on a scale | Day 1, 20 minutes post-CAC | eyes | Participants |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Epinastine 0.05% | Ophthalmic solution, 1 drop instilled in 1 eye, as randomized. | 0 | 50 | 0 | 50 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |