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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01999348
• Collaborator: (none)
• Enrollment: 1,553
• Location: 1
• Actual Duration (Months): 12.8
• Patients Per Site Per Month: 121.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Primary Open Angle; Ocular Hypertension	Drug: Fixed Combination Bimatoprost and Timolol

Study Design

• Study Type: Observational
• Actual Enrollment: 1553 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Actual Study Start Date: Nov 25, 2013
• Actual Primary Completion Date: Dec 19, 2014
• Actual Study Completion Date: Dec 19, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Wiesloch		Germany

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01999348
• Other Study ID Numbers: MAF/AGN/OPH/GLA/039
• First Posted: Dec 3, 2013
• Last Update Posted: Apr 19, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension; Timolol; Bimatoprost

Study Results

Participant Flow

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Period Title: Overall Study
STARTED	1553
COMPLETED	1433
NOT COMPLETED	120

Baseline Characteristics

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Overall Participants	1553
Age, Customized (participants) [Number]
Less than 18 years	1 0.1%
18 to 30 years	8 0.5%
31 to 40 years	21 1.4%
41 to 50 years	119 7.7%
51 to 60 years	313 20.2%
61 to 70 years	415 26.7%
71 to 80 years	477 30.7%
81 to 90 years	155 10%
Greater than or equal to 91	8 0.5%
Missing data	36 2.3%
Sex/Gender, Customized (participants) [Number]
Female	913 58.8%
Male	631 40.6%
Missing data	9 0.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses.

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1321
Baseline	22.18 (3.55)
Final Visit	16.11 (2.87)

2. Secondary Outcome

Title	Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale
Description	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.
Time Frame	Baseline, Final Visit (Week 8 to 12)

Outcome Measure Data

Analysis Population Description

Per-protocol population included all treated participants who had no major protocol violations.

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1391
Better than expected	497 32%
As expected	729 46.9%
Worse than expected	98 6.3%
Missing data	67 4.3%

3. Secondary Outcome

Title	Patient Assessment of Tolerability on a 4-Point Scale
Description	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.
Time Frame	Final Visit (Week 8 to 12)

Outcome Measure Data

Analysis Population Description

Per-protocol population included all treated participants who had no major protocol violations.

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1391
Very good	788 50.7%
Good	461 29.7%
Moderate	45 2.9%
Poor	50 3.2%
Missing	47 3%

4. Secondary Outcome

Title	Physician Assessment of Tolerability on a 4-Point Scale
Description	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.
Time Frame	Final Visit (Week 8 to 12)

Outcome Measure Data

Analysis Population Description

Per-protocol population included all treated participants who had no major protocol violations.

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1391
Very good	809 52.1%
Good	474 30.5%
Moderate	40 2.6%
Poor	28 1.8%
Missing	40 2.6%

5. Secondary Outcome

Title	Percentage of Patients Who Discontinued Treatment
Description	The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit
Time Frame	12 Weeks

Outcome Measure Data

Analysis Population Description

Per-protocol population included all treated participants who had no major protocol violations.

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1391
Number [percentage of participants]	6.47 0.4%

6. Secondary Outcome

Title	Percentage of Patients Prescribed by the Physician to Continue Treatment
Description	The percentage of participants who continued treatment with Ganfort® UD after Week 12.
Time Frame	Final Visit (Week 8 to 12)

Outcome Measure Data

Analysis Population Description

Per-protocol population included all treated participants who had no major protocol violations.

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1391
Number [percentage of participants]	89.14 5.7%

7. Secondary Outcome

Title	Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
Description	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.
Time Frame	Final Visit (Week 8 to 12)

Outcome Measure Data

Analysis Population Description

All participants from the Per-protocol population, all treated participants who had no major protocol violations, who received previous treatment.

Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
Measure Participants	1352
Better	727 46.8%
Equal	542 34.9%
Worse	34 2.2%
Missing	49 3.2%

Adverse Events

Time Frame	Up to 12 Weeks
Adverse Event Reporting Description	Participating physicians were required to document all serious adverse events (SAEs), irrespective of relationship, and all non-serious adverse drug reactions (ADRs).
Arm/Group Title	Patients With POAG or OHT
Arm/Group Description	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.
All Cause Mortality
	Patients With POAG or OHT
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Patients With POAG or OHT
	Affected / at Risk (%)	# Events
Total	1/1553 (0.1%)
General disorders
Death	1/1553 (0.1%)
Other (Not Including Serious) Adverse Events
	Patients With POAG or OHT
	Affected / at Risk (%)	# Events
Total	0/1553 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.