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The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-4943A | Experimental | Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine Hydrochloride Ophthalmic Solution, 0.2% | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Itching Score by Visit | Ocular itching will be assessed by the subject and graded on a 6-point scale, where 0=did not occur and 5=virtually all the time over the past 3 days. | Up to Week 10 |
| Mean Total Hyperemia Score by Visit | Ocular hyperemia (redness) will be assessed by the investigator. Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctival scores. | Up to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Subjective Symptoms by Visit | Up to Week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Center | Osaka | Osaka | 532-0003 | Japan |
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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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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |