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 -
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Osaka, 일본
- Santen study sites
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Ocular Itching Score by Visit
기간: From baseline to 8-week
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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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Palpebral Hyperemia Score by Visit
기간: From baseline to 8-week
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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
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Change in Bulbar Conjunctiva Hyperemia Score by Visit
기간: From baseline to 8-week
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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