Trial Outcomes & Findings for A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting (NCT NCT01999348)

NCT ID: NCT01999348

Last Updated: 2019-04-19

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

1553 participants

Primary outcome timeframe

Baseline, Final Visit (Week 8 to 12)

Results posted on

2019-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1553
Overall Study COMPLETED	1433
Overall Study NOT COMPLETED	120

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With POAG or OHT n=1553 Participants 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.
Age, Customized Less than 18 years	1 participants n=5 Participants
Age, Customized 18 to 30 years	8 participants n=5 Participants
Age, Customized 31 to 40 years	21 participants n=5 Participants
Age, Customized 41 to 50 years	119 participants n=5 Participants
Age, Customized 51 to 60 years	313 participants n=5 Participants
Age, Customized 61 to 70 years	415 participants n=5 Participants
Age, Customized 71 to 80 years	477 participants n=5 Participants
Age, Customized 81 to 90 years	155 participants n=5 Participants
Age, Customized Greater than or equal to 91	8 participants n=5 Participants
Age, Customized Missing data	36 participants n=5 Participants
Sex/Gender, Customized Female	913 participants n=5 Participants
Sex/Gender, Customized Male	631 participants n=5 Participants
Sex/Gender, Customized Missing data	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Final Visit (Week 8 to 12)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1321 Participants 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.
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye Baseline	22.18 mmHg Standard Deviation 3.55
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye Final Visit	16.11 mmHg Standard Deviation 2.87

SECONDARY outcome

Timeframe: Baseline, Final Visit (Week 8 to 12)

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

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.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1391 Participants 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.
Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale Better than expected	497 participants
Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale As expected	729 participants
Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale Worse than expected	98 participants
Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale Missing data	67 participants

SECONDARY outcome

Timeframe: Final Visit (Week 8 to 12)

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

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.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1391 Participants 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.
Patient Assessment of Tolerability on a 4-Point Scale Very good	788 participants
Patient Assessment of Tolerability on a 4-Point Scale Good	461 participants
Patient Assessment of Tolerability on a 4-Point Scale Moderate	45 participants
Patient Assessment of Tolerability on a 4-Point Scale Poor	50 participants
Patient Assessment of Tolerability on a 4-Point Scale Missing	47 participants

SECONDARY outcome

Timeframe: Final Visit (Week 8 to 12)

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

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.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1391 Participants 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.
Physician Assessment of Tolerability on a 4-Point Scale Missing	40 participants
Physician Assessment of Tolerability on a 4-Point Scale Good	474 participants
Physician Assessment of Tolerability on a 4-Point Scale Moderate	40 participants
Physician Assessment of Tolerability on a 4-Point Scale Poor	28 participants
Physician Assessment of Tolerability on a 4-Point Scale Very good	809 participants

SECONDARY outcome

Timeframe: 12 Weeks

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

The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1391 Participants 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.
Percentage of Patients Who Discontinued Treatment	6.47 percentage of participants

SECONDARY outcome

Timeframe: Final Visit (Week 8 to 12)

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

The percentage of participants who continued treatment with Ganfort® UD after Week 12.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1391 Participants 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.
Percentage of Patients Prescribed by the Physician to Continue Treatment	89.14 percentage of participants

SECONDARY outcome

Timeframe: Final Visit (Week 8 to 12)

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

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.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=1352 Participants 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.
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale Better	727 participants
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale Equal	542 participants
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale Worse	34 participants
Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale Missing	49 participants

Adverse Events

Patients With POAG or OHT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With POAG or OHT n=1553 participants at risk 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.
General disorders Death	0.06% 1/1553 • Up to 12 Weeks Participating physicians were required to document all serious adverse events (SAEs), irrespective of relationship, and all non-serious adverse drug reactions (ADRs).

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER