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

Completed

• Conditions: Ocular Hypertension; Glaucoma, Primary Open Angle
• Interventions: Drug: Fixed Combination Bimatoprost and Timolol

• Registration Number: NCT01999348
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-25
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-03
• Primary Completion: 2014-12-19
• Study Completion: 2014-12-19
• Results First Submitted: 2015-11-03
• Results First Submitted QC: 2015-11-03
• Results First Posted: 2015-12-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1553

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with POAG or OHT	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye	Baseline, Final Visit (Week 8 to 12)	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).

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Tolerability on a 4-Point Scale	Final Visit (Week 8 to 12)	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.
Percentage of Patients Who Discontinued Treatment	12 Weeks	The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit
Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale	Baseline, Final Visit (Week 8 to 12)	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.
Physician Assessment of Tolerability on a 4-Point Scale	Final Visit (Week 8 to 12)	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.
Percentage of Patients Prescribed by the Physician to Continue Treatment	Final Visit (Week 8 to 12)	The percentage of participants who continued treatment with Ganfort® UD after Week 12.
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale	Final Visit (Week 8 to 12)	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.