- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Flemish Brabant
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Leuven, Flemish Brabant, Belgium, B-3000
- University Hospitals Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Glaucoma Symptom Scale questionnaire
Time Frame: 8 weeks
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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.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Functional-related items of the Glaucoma Symptom Scale
Time Frame: 8 weeks
|
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.
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8 weeks
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Change in Symptom-related items of the Glaucoma Symptom Scale
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-53534
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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