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

Phase 4

• Conditions: Glaucoma; Hypertension

• Registration Number: NCT01125306
• Lead Sponsor: Meir Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-05-16
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Primary Completion: 2011-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Consumption of Xalatan/Xalacom bottles per year per patient.	12 months.

Secondary Outcome Measures

Name	Time	Method
Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease	12 months
Characterizing the optimal conditions for proper usage of the Xal-Ease device	12 months

Trial Locations

Locations (1)

Ophthalmology department, Meir Medical Center; 🇮🇱 Kfar-Saba, Israel