A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -
調査の概要
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 a Type I allergy 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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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 |
---|---|---|
Change in Ocular Itching Score by Visit
時間枠:From baseline to 8-week
|
Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. |
From baseline to 8-week
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Palpebral Hyperemia Score by Visit
時間枠:From baseline to 8-week
|
Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. |
From baseline to 8-week
|
Change in Bulbar Conjunctiva Hyperemia Score by Visit
時間枠:From baseline to 8-week
|
Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined. |
From baseline to 8-week
|
協力者と研究者
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
- 01141102
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。