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

Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923714
• Other study ID #: S-53534
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: August 13, 2013
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients aged over 18 years old at inclusion visit

• Diagnosed as having OAG in one or both eyes

• Who have used the previous preserved eye drops treatment for at least 4 weeks in one eye or both eyes

• Experiencing pre-established ocular surface disease symptoms, as defined in the 2007 report of the International Dry Eye Workshop

• Being scheduled by their ophthalmologist for a switch to preservative-free DTFC eye drops (as monotherapy or replacement of one preserved product of a combined therapy) at inclusion visit due to tolerability issues

• Accepting to participate in the study and who has provided a written informed consent

Exclusion Criteria:

• Patients who had filtering or other ocular surgery within the 6 months preceding the inclusion visit

• Who have already been treated with preservative-free DTFC

• Whose visual acuity is importantly impaired by a severe ocular disease other than OAG, as assessed by the physician

• Currently involved in a clinical trial or study cohort or pharmaco-epidemiology study or interventional study

• With serious mental or physical disability which could interfere with a patient-reported assessment

• Pregnant women.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Flemish Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glaucoma Symptom Scale questionnaire	The main study objective was to assess a change in the patient-reported Glaucoma Symptom Scale questionnaire, filled in at baseline (Week 0) and at the end of the 8 week of therapy with preservative-free DTFC.	8 weeks	No
Secondary	Change in Functional-related items of the Glaucoma Symptom Scale	A secondary outcome was to assess a change in the patient-reported Glaucoma Symptom Scale questionnaire functional parameters, filled in at baseline (Week 0) and week 4 and week 8 of therapy with preservative-free DTFC.	8 weeks	No
Secondary	Change in Symptom-related items of the Glaucoma Symptom Scale	A secondary outcome was to assess a change in the patient-reported Glaucoma Symptom Scale questionnaire symptomatic parameters, filled in at baseline (Week 0) and week 4 and week 8 of therapy with preservative-free DTFC.	8 weeks	No