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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999348
• Other study ID #: MAF/AGN/OPH/GLA/039
• Status: Completed
• Start date: November 25, 2013
• Est. completion date: December 19, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1553
• Est. completion date: December 19, 2014
• Est. primary completion date: December 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle
• Hypertension
• Ocular Hypertension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pfennigsdorf S, Eschstruth P, Häsemeyer 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. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)