A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting

The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Primary Open Angle
• Intervention / Treatment: Drug: Fixed Combination Bimatoprost and Timolol

• Study Type: Observational
• Enrollment (Actual): 1553

Contacts and Locations

Study Locations

• Germany
  • Wiesloch, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary open-angle glaucoma or ocular hypertension

Description

Inclusion Criteria:

• Diagnosed with primary open-angle glaucoma or ocular hypertension
• Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with POAG or OHT; Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.	Drug: Fixed Combination Bimatoprost and Timolol; Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.; Other Names: GANFORT® UD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye	IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).	Baseline, Final Visit (Week 8 to 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale	The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.	Baseline, Final Visit (Week 8 to 12)
Patient Assessment of Tolerability on a 4-Point Scale	The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.	Final Visit (Week 8 to 12)
Physician Assessment of Tolerability on a 4-Point Scale	The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.	Final Visit (Week 8 to 12)
Percentage of Patients Who Discontinued Treatment	The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit	12 Weeks
Percentage of Patients Prescribed by the Physician to Continue Treatment	The percentage of participants who continued treatment with Ganfort® UD after Week 12.	Final Visit (Week 8 to 12)
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale	The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.	Final Visit (Week 8 to 12)

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Pfennigsdorf S, Eschstruth P, Hasemeyer S, Feuerhake C, Brief G, Grobeiu I, Shirlaw A. Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice. Clin Ophthalmol. 2016 Sep 20;10:1837-1846. doi: 10.2147/OPTH.S106159. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2013
• Primary Completion (Actual): December 19, 2014
• Study Completion (Actual): December 19, 2014

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Bimatoprost
• Other Study ID Numbers: MAF/AGN/OPH/GLA/039