Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Double-masked, Comparison Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3, Confirmatory Study -
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Osaka、日本
- Santen study sites
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Provided signed, written informed consent.
- Has a positive result from an allergen-specific IgE antibody test.
- If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Exclusion Criteria:
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- Presence of any abnormality or significant illness that could be expected to interfere with the study.
研究計画
研究はどのように設計されていますか？
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
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他の名前：
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プラセボコンパレーター：2
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アクティブコンパレータ：3
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Ocular Itching Score Compared to Placebo Period1
時間枠：Visit 5 (3, 5, and 10 minutes post-CAC)
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A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge . |
Visit 5 (3, 5, and 10 minutes post-CAC)
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Mean Hyperemia Score Compared to Placebo Period1
時間枠：Visit 5 (5, 10, and 20 minutes post-CAC)
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A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge . |
Visit 5 (5, 10, and 20 minutes post-CAC)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Ocular Itching Score Compared to Olopatadine Period2
時間枠：Visit 7 (3, 5, and 10 minutes post-CAC)
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A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge . |
Visit 7 (3, 5, and 10 minutes post-CAC)
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Mean Hyperemia Score Compared to Olopatadine Period2
時間枠：Visit 7 (5, 10, and 20 minutes post-CAC)
|
A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge . |
Visit 7 (5, 10, and 20 minutes post-CAC)
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 01141101
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