- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00626067
Study of Patient Use and Perception of the Travatan Dosing Aid
Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):
- Fully functional Travatan compliance monitor
- Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
- Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.
At end of study, patients fill out questionnaire assessing
- Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
- patient's belief as to whether their compliance was monitored or not
Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.
The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Open angle glaucoma or ocular hypertension
- Presently using Travatan eye drops
Exclusion Criteria:
- Allergy to prostaglandin
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 1 Fully functional monitoring device
Fully functional monitoring device
|
Pt received fully functional monitoring dispenser for use with their Travatan eye drops
|
|
Aktiv komparator: 2 Partially functional monitoring device
Partially functional monitoring device
|
Patient received a particually functional Travatan Compliance Monitoring Dispenser
|
|
Sham-komparator: 3 Non-functional monitoring device
Non-functional monitoring device
|
Patient received a non functioning Travatan Compliance Monitoring Dispenser
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
Tidsramme: 6 weeks
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pilot study of the impact of physician monitoring of compliance on patient compliance
Tidsramme: 6 weeks
|
6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jonathan S. Myers, MD, Wills Eye Institute
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB #06-762E
- CMS-06-09 (Anden identifikator: Wills Eye Hospital)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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