A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
4 avril 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
48
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Connecticut
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Waterbury, Connecticut, États-Unis, 06708
- The Eye Care Group
-
-
Virginia
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Norfolk, Virginia, États-Unis, 23502
- Virginia Eye Consultants
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
22 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acute Stimulated Tear Production
Délai: 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)
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
|
Corrected Distance Visual Acuity
Délai: 1-Day
|
1-Day
|
|
Slit Lamp Biomicroscopy
Délai: 1-Day
|
1-Day
|
|
Pulse Rate
Délai: 1-Day
|
1-Day
|
|
Oxygen Saturation
Délai: 1-Day
|
1-Day
|
|
Blood Pressure
Délai: 1-Day
|
1-Day
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Michelle Senchyna, Allergan
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
31 janvier 2016
Achèvement primaire (Réel)
31 mars 2016
Achèvement de l'étude (Réel)
31 mars 2016
Dates d'inscription aux études
Première soumission
21 janvier 2016
Première soumission répondant aux critères de contrôle qualité
8 février 2016
Première publication (Estimation)
11 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 avril 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 avril 2019
Dernière vérification
1 avril 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OCUN-009
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .