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

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Drug: Fixed combination 0.3 mg bimatoprost and 5 mg timolol

• Registration Number: NCT01628601
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-27
• Status Verified: 2012-08
• Results First Submitted: 2012-08-21
• Results First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Results First Posted: 2012-09-24
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POAG or OHT	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP)	Baseline, 18 Weeks	IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

Secondary Outcome Measures

Name	Time	Method
Physician Assessment of Tolerability Using a 4-Point Scale	18 Weeks	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.
Patient Assessment of Tolerability Using a 4-Point Scale	18 Weeks	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.
Physician Assessment of Adherence to GANfort®	18 Weeks	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.
Patients Continuing With GANfort® After 18 Weeks	18 Weeks	Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.