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

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ClinicalTrials.gov Identifier: NCT01923714
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease
Open Angle 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.


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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of a Tolerability Switch to Dorzolamide/Timolol Preservative-free Fixed Combination on Ocular Surface Symptoms in Belgian Glaucoma Patients
Study Start Date : August 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012


Group/Cohort
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.



Primary Outcome Measures :
  1. Change in Glaucoma Symptom Scale questionnaire [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with OAG that require topical therapy for intraocular pressure lowering and that were scheduled to switch current therapy to preservative-free DTFC
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923714


Locations
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Belgium
University Hospitals Leuven
Leuven, Flemish Brabant, Belgium, B-3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Ingeborg Stalmans, MD, PhD UZ Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01923714     History of Changes
Other Study ID Numbers: S-53534
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: December 2012

Keywords provided by Universitaire Ziekenhuizen Leuven:
Glaucoma

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Timolol
Dorzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors