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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01923714
Collaborator
(none)
103
Enrollment
1
Location
14
Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Aug 1, 2011
    Actual Primary Completion Date :
    Oct 1, 2012
    Actual Study Completion Date :
    Oct 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Glaucoma Symptom Scale questionnaire [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Leuven Leuven Flemish Brabant Belgium B-3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Ingeborg Stalmans, MD, PhD, UZ Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01923714
    Other Study ID Numbers:
    • S-53534
    First Posted:
    Aug 15, 2013
    Last Update Posted:
    Aug 15, 2013
    Last Verified:
    Dec 1, 2012
    Keywords provided by Universitaire Ziekenhuizen Leuven
    Glaucoma
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of Aug 15, 2013