Trial Outcomes & Findings for GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy (NCT NCT01628601)

NCT ID: NCT01628601

Last Updated: 2012-09-24

Results Overview

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

• Recruitment status: COMPLETED
• Target enrollment: 392 participants
• Primary outcome timeframe: Baseline, 18 Weeks
• Results posted on: 2012-09-24

Participant Flow

Participant milestones

Measure	POAG or OHT 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
Overall Study STARTED	392
Overall Study COMPLETED	351
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	POAG or OHT n=392 Participants 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
Age Continuous	67.22 Years STANDARD_DEVIATION 13.14 • n=5 Participants
Sex/Gender, Customized Female	232 Participants n=5 Participants
Sex/Gender, Customized Male	155 Participants n=5 Participants
Sex/Gender, Customized Missing Data	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 18 Weeks

Population: All enrolled patients with complete data for this outcome measure

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

Outcome measures

Measure	POAG or OHT n=345 Participants 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
Change From Baseline in Intraocular Pressure (IOP) Baseline - Right Eye (N=345)	22.0 Millimeters of Mercury (mmHg) Interval 18.0 to 24.0
Change From Baseline in Intraocular Pressure (IOP) Change from Baseline at 18 Wks-Rt Eye (N=345)	-6.0 Millimeters of Mercury (mmHg) Interval -7.0 to -3.0
Change From Baseline in Intraocular Pressure (IOP) Baseline - Left Eye (N=344)	22.0 Millimeters of Mercury (mmHg) Interval 19.0 to 25.0
Change From Baseline in Intraocular Pressure (IOP) Change from Baseline at 18 Wks-Lft Eye (N=344)	-6.0 Millimeters of Mercury (mmHg) Interval -7.0 to -4.0

SECONDARY outcome

Timeframe: 18 Weeks

Population: All enrolled patients with complete data for this outcome measure

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.

Outcome measures

Measure	POAG or OHT n=356 Participants 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
Physician Assessment of Tolerability Using a 4-Point Scale	340 Participants

SECONDARY outcome

Timeframe: 18 Weeks

Population: All enrolled patients with complete data for this outcome measure

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.

Outcome measures

Measure	POAG or OHT n=349 Participants 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
Patient Assessment of Tolerability Using a 4-Point Scale	319 Participants

SECONDARY outcome

Timeframe: 18 Weeks

Population: All enrolled patients with complete data for this outcome measure

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.

Outcome measures

Measure	POAG or OHT n=310 Participants 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
Physician Assessment of Adherence to GANfort®	112 Participants

SECONDARY outcome

Timeframe: 18 Weeks

Population: All enrolled patients with complete data for this outcome measure

Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.

Outcome measures

Measure	POAG or OHT n=355 Participants 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
Patients Continuing With GANfort® After 18 Weeks	329 Participants

Adverse Events

POAG or OHT

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	POAG or OHT n=392 participants at risk 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
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.26% 1/392

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

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