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Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom

Primary Purpose

Glaucoma, Hypertension

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Xal-Ease

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring Drug consumption, The Xal-Ease device, Patient's compliance, Using a novel Pfizer-Pharmacia device to facilitate the Xalatan/Xalacom instillation and to avoid loss of eye drops

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with glaucoma or hypertension treated with Xalatan/Xalacom who have consumed more than one bottle per month within a year prior to initiation of the study.

Exclusion Criteria:

Patients younger than 18 years,
Patients with severe manual disabilities,
Patients with impaired cognition and mentality.

Sites / Locations

Ophthalmology department, Meir Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Consumption of Xalatan/Xalacom bottles per year per patient.

Secondary Outcome Measures

Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease

Characterizing the optimal conditions for proper usage of the Xal-Ease device

Full Information

NCT ID

NCT01125306

First Posted

May 16, 2010

Last Updated

March 15, 2012

Sponsor

Meir Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01125306

Brief Title

Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meir Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect instillation. Patients on Xalatan/Xalacom who have consumed more than one bottle per month within a year according to consumption data drawn from the Clalit Health Services database, will use the Xal-Ease device for a year. The device is expected to reduce consumption of bottles and result in saving money for both patients and medical care providers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Hypertension

Keywords

Drug consumption, The Xal-Ease device, Patient's compliance, Using a novel Pfizer-Pharmacia device to facilitate the Xalatan/Xalacom instillation and to avoid loss of eye drops

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Xal-Ease

Other Intervention Name(s)

Xal-Ease as a Pfizer-Pharmacia device.

Intervention Description

Xal-Ease device used to facilitate application of Xalatan/Xalacom eye drops.

Primary Outcome Measure Information:

Title

Consumption of Xalatan/Xalacom bottles per year per patient.

Time Frame

12 months.

Secondary Outcome Measure Information:

Title

Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease

Time Frame

12 months

Title

Characterizing the optimal conditions for proper usage of the Xal-Ease device

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with glaucoma or hypertension treated with Xalatan/Xalacom who have consumed more than one bottle per month within a year prior to initiation of the study. Exclusion Criteria: Patients younger than 18 years, Patients with severe manual disabilities, Patients with impaired cognition and mentality.

Facility Information:

Facility Name

Ophthalmology department, Meir Medical Center

City

Kfar-Saba

ZIP/Postal Code

44281

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronit Nesher, MD

Phone

972-9747555

Ext

2774

nesher.ronit@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Ronit Nesher, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

17208672

Citation

Semes L, Shaikh AS. Evaluation of the Xal-Ease latanoprost delivery system. Optometry. 2007 Jan;78(1):30-3. doi: 10.1016/j.optm.2006.06.016.

Results Reference

background

PubMed Identifier

19882583

Citation

Nordmann JP, Baudouin C, Bron A, Denis P, Rouland JF, Sellem E, Renard JP. Xal-Ease: impact of an ocular hypotensive delivery device on ease of eyedrop administration, patient compliance, and satisfaction. Eur J Ophthalmol. 2009 Nov-Dec;19(6):949-56. doi: 10.1177/112067210901900609.

Results Reference

result

Links:

URL

http://www.xalatan.com/tools/xal-ease.aspx

Description

Related Info

Learn more about this trial

Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom

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