A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
2019년 4월 4일 업데이트: Oculeve, Inc.
A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye
The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.
연구 개요
상세 설명
This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.
연구 유형
중재적
등록 (실제)
48
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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Waterbury, Connecticut, 미국, 06708
- The Eye Care Group
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Virginia
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Norfolk, Virginia, 미국, 23502
- Virginia Eye Consultants
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
22년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Participants with aqueous tear deficiency
- Literate, able to speak English or Spanish, and able to complete questionnaires independently
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
Exclusion Criteria:
- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding
- Nasal or sinus surgery including nasal cautery or significant trauma
- Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device
- Diagnosis of epilepsy
- Corneal transplant in either or both eyes
- Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
- A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Sequence 1-Intranasal: Extranasal: Sham
Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
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Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve device, extranasal (control) application for approximately 3 minutes.
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실험적: Sequence 2-Intranasal: Sham: Extranasal
Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
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Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve device, extranasal (control) application for approximately 3 minutes.
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실험적: Sequence 3-Extranasal: Intranasal: Sham
Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
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Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve device, extranasal (control) application for approximately 3 minutes.
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실험적: Sequence 4-Extranasal: Sham: Intranasal
Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
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Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve device, extranasal (control) application for approximately 3 minutes.
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실험적: Sequence 5-Sham: Intranasal: Extranasal
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
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Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve device, extranasal (control) application for approximately 3 minutes.
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실험적: Sequence 6-Sham: Extranasal: Intranasal
Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.
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Oculeve device, intranasal (test) application for approximately 3 minutes.
Sham device (control), intranasal application for approximately 3 minutes.
Oculeve device, extranasal (control) application for approximately 3 minutes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Acute Stimulated Tear Production
기간: Day 0 post-application
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Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal).
The Schirmer strip is placed just under the eyelid and wicks up the tears.
It measures tear production on a linear scale of 0-35 mm.
The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected.
If there was no difference for either measure, the right eye was used as the study eye.
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Day 0 post-application
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Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
기간: Day 0
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An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device.
Device-related AEs were presented as ocular and non-ocular.
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Day 0
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기타 결과 측정
결과 측정 |
기간 |
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Corrected Distance Visual Acuity
기간: 1-Day
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1-Day
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Slit Lamp Biomicroscopy
기간: 1-Day
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1-Day
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Pulse Rate
기간: 1-Day
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1-Day
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Oxygen Saturation
기간: 1-Day
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1-Day
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Blood Pressure
기간: 1-Day
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1-Day
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Michelle Senchyna, Allergan
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 1월 31일
기본 완료 (실제)
2016년 3월 31일
연구 완료 (실제)
2016년 3월 31일
연구 등록 날짜
최초 제출
2016년 1월 21일
QC 기준을 충족하는 최초 제출
2016년 2월 8일
처음 게시됨 (추정)
2016년 2월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 4월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 4일
마지막으로 확인됨
2019년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
건성각결막염에 대한 임상 시험
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University Hospital, Clermont-Ferrand알려지지 않은
Oculeve Intranasal에 대한 임상 시험
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Intersect ENT완전한
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VA Office of Research and Development완전한
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Meissa Vaccines, Inc.모병