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To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis
To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FK506 ophthalmic suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FK506 | Drug | Ophthalmic suspension |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | length of study |
| Measure | Description | Time Frame |
|---|---|---|
| The mean change from the baseline (before the treatment) in total score for objective clinical signs | length of study | |
| Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign | Length of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ehime | Japan | |||||
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| Subjective symptom score (Visual Analog Scale) | Length of study |
| The improvement rate | Length of study |
| Hokkaido |
| Japan |
| Kagoshima | Japan |
| Kochi | Japan |
| Miyazaki | Japan |
| Osaka | Japan |
| Tochigi | Japan |
| Tokyo | Japan |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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