Recruitment

Recruitment Status
Completed

Inclusion Criterias

Diagnosed as having OAG in one or both eyes
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
...
Diagnosed as having OAG in one or both eyes
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
Who have used the previous preserved eye drops treatment for at least 4 weeks in one eye or both eyes
Adults patients aged over 18 years old at inclusion visit
Experiencing pre-established ocular surface disease symptoms, as defined in the 2007 report of the International Dry Eye Workshop

Exclusion Criterias

With serious mental or physical disability which could interfere with a patient-reported assessment
Pregnant women.
Patients who had filtering or other ocular surgery within the 6 months preceding the inclusion visit
...
With serious mental or physical disability which could interfere with a patient-reported assessment
Pregnant women.
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
Currently involved in a clinical trial or study cohort or pharmaco-epidemiology study or interventional study
Whose visual acuity is importantly impaired by a severe ocular disease other than OAG, as assessed by the physician

Summary

Conditions
Open Angle Glaucoma
Type
Observational
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 wa...

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.

Inclusion Criterias

Diagnosed as having OAG in one or both eyes
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
...
Diagnosed as having OAG in one or both eyes
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
Who have used the previous preserved eye drops treatment for at least 4 weeks in one eye or both eyes
Adults patients aged over 18 years old at inclusion visit
Experiencing pre-established ocular surface disease symptoms, as defined in the 2007 report of the International Dry Eye Workshop

Exclusion Criterias

With serious mental or physical disability which could interfere with a patient-reported assessment
Pregnant women.
Patients who had filtering or other ocular surgery within the 6 months preceding the inclusion visit
...
With serious mental or physical disability which could interfere with a patient-reported assessment
Pregnant women.
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
Currently involved in a clinical trial or study cohort or pharmaco-epidemiology study or interventional study
Whose visual acuity is importantly impaired by a severe ocular disease other than OAG, as assessed by the physician

Locations

Leuven, Flemish Brabant, B-3000
Leuven, Flemish Brabant, B-3000

Tracking Information

NCT #
NCT01923714
Collaborators
Not Provided
Investigators
  • Principal Investigator: Ingeborg Stalmans, MD, PhD UZ Leuven
  • Ingeborg Stalmans, MD, PhD UZ Leuven