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A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

4 de abril de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

48

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Connecticut
      • Waterbury, Connecticut, Estados Unidos, 06708
        • The Eye Care Group
    • Virginia
      • Norfolk, Virginia, Estados Unidos, 23502
        • Virginia Eye Consultants

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

22 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Dispositivo: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Dispositivo: Sham
Sham device (control), intranasal application for approximately 3 minutes.
Dispositivo: Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: 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.
Dispositivo: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Dispositivo: Sham
Sham device (control), intranasal application for approximately 3 minutes.
Dispositivo: Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: 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.
Dispositivo: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Dispositivo: Sham
Sham device (control), intranasal application for approximately 3 minutes.
Dispositivo: Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: 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.
Dispositivo: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Dispositivo: Sham
Sham device (control), intranasal application for approximately 3 minutes.
Dispositivo: Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: 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.
Dispositivo: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Dispositivo: Sham
Sham device (control), intranasal application for approximately 3 minutes.
Dispositivo: Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Experimental: 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.
Dispositivo: Oculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
Dispositivo: Sham
Sham device (control), intranasal application for approximately 3 minutes.
Dispositivo: Oculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acute Stimulated Tear Production
Periodo de tiempo: Day 0 post-application
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.
Day 0 post-application
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
Periodo de tiempo: Day 0
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.
Day 0

Otras medidas de resultado

Medida de resultado
Periodo de tiempo
Corrected Distance Visual Acuity
Periodo de tiempo: 1-Day
1-Day
Slit Lamp Biomicroscopy
Periodo de tiempo: 1-Day
1-Day
Pulse Rate
Periodo de tiempo: 1-Day
1-Day
Oxygen Saturation
Periodo de tiempo: 1-Day
1-Day
Blood Pressure
Periodo de tiempo: 1-Day
1-Day

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Oculeve, Inc.

Investigadores

  • Director de estudio: Michelle Senchyna, Allergan

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de enero de 2016

Finalización primaria (Actual)

31 de marzo de 2016

Finalización del estudio (Actual)

31 de marzo de 2016

Fechas de registro del estudio

Enviado por primera vez

21 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

8 de febrero de 2016

Publicado por primera vez (Estimar)

11 de febrero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de abril de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

4 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • OCUN-009

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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