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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma | Patients with open-angle glaucoma (OAG) that require topical intraocular pressure lowering therapy and that were scheduled to switch current therapy to preservative-free DTFC. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Symptom-related items of the Glaucoma Symptom Scale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with OAG that require topical therapy for intraocular pressure lowering and that were scheduled to switch current therapy to preservative-free DTFC
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| Name | Affiliation | Role |
|---|---|---|
| Ingeborg Stalmans, MD, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Flemish Brabant | B-3000 | Belgium |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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 |