A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
4 april 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
48
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Connecticut
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Waterbury, Connecticut, Verenigde Staten, 06708
- The Eye Care Group
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Virginia
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Norfolk, Virginia, Verenigde Staten, 23502
- Virginia Eye Consultants
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
22 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Experimenteel: 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.
|
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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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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Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Acute Stimulated Tear Production
Tijdsspanne: 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.
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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)
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Corrected Distance Visual Acuity
Tijdsspanne: 1-Day
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1-Day
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Slit Lamp Biomicroscopy
Tijdsspanne: 1-Day
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1-Day
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Pulse Rate
Tijdsspanne: 1-Day
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1-Day
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Oxygen Saturation
Tijdsspanne: 1-Day
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1-Day
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Blood Pressure
Tijdsspanne: 1-Day
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1-Day
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Michelle Senchyna, Allergan
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 januari 2016
Primaire voltooiing (Werkelijk)
31 maart 2016
Studie voltooiing (Werkelijk)
31 maart 2016
Studieregistratiedata
Eerst ingediend
21 januari 2016
Eerst ingediend dat voldeed aan de QC-criteria
8 februari 2016
Eerst geplaatst (Schatting)
11 februari 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 april 2019
Laatste update ingediend die voldeed aan QC-criteria
4 april 2019
Laatst geverifieerd
1 april 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- OCUN-009
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
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