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NCT01125306 Clinical Trial

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

Hypertension Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01125306
Other study ID # GLAUCOMA/XAL EASE 1
Secondary ID
Status Recruiting
Phase Phase 4
First received May 16, 2010
Last updated March 15, 2012
Start date June 2009
Est. completion date October 2012

Study information
Verified date March 2012
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date October 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Ophthalmology department, Meir Medical Center Kfar-Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

Semes L, Shaikh AS. Evaluation of the Xal-Ease latanoprost delivery system. Optometry. 2007 Jan;78(1):30-3. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Consumption of Xalatan/Xalacom bottles per year per patient. 12 months. No
Secondary Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease 12 months No
Secondary Characterizing the optimal conditions for proper usage of the Xal-Ease device 12 months No
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