GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628601
• Other study ID #: MAF/AGN/OPH/GLA/027
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: August 21, 2012
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Intraocular Pressure (IOP)	IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.	Baseline, 18 Weeks	No
Secondary	Physician Assessment of Tolerability Using a 4-Point Scale	Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.	18 Weeks	No
Secondary	Patient Assessment of Tolerability Using a 4-Point Scale	Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.	18 Weeks	No
Secondary	Physician Assessment of Adherence to GANfort®	Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as "better" compliance are reported.	18 Weeks	No
Secondary	Patients Continuing With GANfort® After 18 Weeks	Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.	18 Weeks	No