NCT01923714

Impact of a Tolerability Switch to Dorzolamide/Timolol Preservative-free Fixed Combination on Ocular Surface Symptoms

Impact of a Tolerability Switch to Dorzolamide/Timolol Preservative-free Fixed Combination on Ocular Surface Symptoms in Belgian Glaucoma Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims at validating in real-life clinical practice and using the self-reported Glaucoma Symptom Scale (GSS) questionnaire, the impact of a switch to preservative-free dorzolamide/timolol fixed combination (DTFC) in patients using preserved topical therapy for glaucoma.

Detailed description

The study is an 8-week multi-center, prospective, observational and non-interventional, open-label study aiming at assessing a change in visual-related quality of life of glaucoma patients that switch therapy to preservative-free DTFC. As a non-interventional study, the decision for the to switch was at the discretion of the physician. Patients scheduled to switch therapy to preservative free DTFC will be asked to fill in the 10 item, linkert-type GSS questionnaire at baseline, at week 4 and at week 8 of therapy switch. The study data will be collected at a baseline and at 2 follow-up visits occurring 4 weeks +/- 1 week and 8 weeks +/- 1 week. If no visit was scheduled, the patient was asked to send the completed documents to the physician.

Conditions

• Open Angle Glaucoma

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-08-15
• Last updated: 2013-08-15

Locations

1 site across 1 country: Belgium