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

NCT01923714 | Completed

• 1 other identifier: S-53534
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in Functional-related items of the Glaucoma Symptom Scale

  8 weeks

• Change in Symptom-related items of the Glaucoma Symptom Scale

  8 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Flemish Brabant, B-3000, Belgium

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Ingeborg Stalmans, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: August 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 15, 2013

Record last verified: 2012-12

Locations

BE (1)