GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy
Brief Summary
Skip to Participation Criteria
This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their physician.
- Study Type: Observational
- Study Design: Observational Model: Cohort, Time Perspective: Prospective
- Study Primary Completion Date: June 2011
Interventions Used in this Clinical Trial
- Drug: Fixed combination 0.3 mg bimatoprost and 5 mg timolol
- Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
Arms, Groups and Cohorts in this Clinical Trial
- POAG or OHT
- Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
Outcome Measures for this Clinical Trial
Primary Measures
- Change From Baseline in Intraocular Pressure (IOP)
- Time Frame: Baseline, 18 Weeks
Safety Issue?: No
- Time Frame: Baseline, 18 Weeks
Secondary Measures
- Physician Assessment of Tolerability Using a 4-Point Scale
- Time Frame: 18 Weeks
Safety Issue?: No
- Time Frame: 18 Weeks
- Patient Assessment of Tolerability Using a 4-Point Scale
- Time Frame: 18 Weeks
Safety Issue?: No
- Time Frame: 18 Weeks
- Physician Assessment of Adherence to GANfort®
- Time Frame: 18 Weeks
Safety Issue?: No
- Time Frame: 18 Weeks
- Patients Continuing With GANfort® After 18 Weeks
- Time Frame: 18 Weeks
Safety Issue?: No
- Time Frame: 18 Weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria
- Diagnosis of primary open angle glaucoma or ocular hypertension
- Prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol)
Exclusion Criteria
- None
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- Allergan
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Medical Director, Study Director, Allergan
Additional Information on this Clinical Trial
Information obtained from ClinicalTrials.gov on May 16, 2013
Link to the current ClinicalTrials.gov record. - http://clinicaltrials.gov/show/NCT01628601
Study ID Number: MAF/AGN/OPH/GLA/027
ClinicalTrials.gov Identifier: NCT01628601
Health Authority: Austria: Agency for Health and Food Safety